Alerts and recalls for drugs and medical devices

• From: Medicines and Healthcare products Regulatory Agency

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• Adalat LA 60mg Tablets incorrectly packaged in 30mg carton (CLDA (16)A/08)

  Quadrant Pharmaceuticals Limited (repackaged by Pharmagen Limited) are asking pharmacists to check stocks of Adalat LA 30mg as there is a possibility that some packs of Parallel Imported LA 60mg may have been incorrectly repackaged.

  • Alert type: Drug alert: company-led
  • Issued: 29 September 2016

• Field Safety Notices - 12 - 16 September 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 12 - 16 September 2016

  • Alert type: Field safety notice
  • Issued: 19 September 2016

• Field Safety Notices - 19 - 23 September 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 September 2016

  • Alert type: Field safety notice
  • Issued: 26 September 2016

• Chlorhexidine Gluconate 2%w/v impregnated pad - precautionary recall (CLDA (16)A/07)

  Sage Products Cooperatief UA: Precautionary recall of five batches due to low risk of microbiological contamination

  • Alert type: Drug alert: company-led
  • Issued: 20 September 2016

• Class 4 Caution in Use: EcoLab Klerpack BD Syringe Multi-Pack

  Ecolab are recalling batches of Klerpack BD Syringe Multi-Pack as the sterile packaging may contain small holes in the film of the pouch. (EL (16)A/13)

  • Alert type: Drug alert
  • Issued: 14 September 2016

• Field Safety Notices - 5 - 9 September 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 5 - 9 September 2016

  • Alert type: Field safety notice
  • Issued: 12 September 2016

• Class 2 medicines recall: GlucaGen HypoKit 1mg (glucagon) PL 04668/0027 (GlucaGen 1mg) PL 04668/0028 (Solvent for GlucaGen 1mg)

  Action within 48 hours: Novo Nordisk Ltd. is recalling seven batches of GlucaGen HypoKit due to a small number of needles being detached from the syringe.

  • Alert type: Drug alert
  • Medical specialism: Critical care
  • Issued: 6 September 2016

• Field Safety Notices - 29 August - 2 September 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August - 2 September 2016

  • Alert type: Field safety notice
  • Issued: 5 September 2016

• AIRVO™2 and myAIRVO™2 humidifier – risk of undetected auditory alarm

  Manufactured by Fisher & Paykel Healthcare Ltd – updated instructions for use to check the speaker before each use as undetected auditory alarms could result in the patient becoming hypoxic.

  • Alert type: Medical device alert
  • Issued: 2 September 2016

• Accu-Chek® Insight Insulin pump system: risk of over- or under-infusion of insulin

  Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis.

  • Alert type: Medical device alert
  • Issued: 1 September 2016

• Field Safety Notices - 22 - 26 August 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 August 2016

  • Alert type: Field safety notice
  • Issued: 30 August 2016

• Class 4 Caution in Use: Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase)

  Reports that rubber stopper may be pushed into vial during reconstitution, rendering the vial unusable. (EL (16)A/11)

  • Alert type: Drug alert
  • Issued: 24 August 2016

• Field Safety Notices - 15 - 19 August 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 15 - 19 August 2016

  • Alert type: Field safety notice
  • Issued: 22 August 2016

• Field safety Notice - 8 August to 12 August

  Summary List of field safety notices (FSNs) from medical device manufacturers from 8 - 12 August 2016

  • Alert type: Field safety notice
  • Issued: 17 August 2016

• Accu-Chek® Insight insulin pump system manufactured by Roche Diabetes Care with NovoRapid® PumpCart® cartridges – risk of hyperglycaemia

  Cartridges inserted incorrectly can leak insulin into the cartridge compartment, resulting in an under-delivery of insulin, which may lead to rapid deterioration of health, diabetic ketoacidosis or death.

  • Alert type: Medical device alert
  • Issued: 15 August 2016

• Helixate NexGen - (CLDA (16)A/06)

  CSL Behring is recalling the listed batches due to reduced potency of the active ingredient.

  • Alert type: Drug alert: company-led
  • Issued: 11 August 2016

• Kogenate Bayer Powder and Solvent for Solution for Injection - (CLDA (16)A/05)

  Bayer is recalling the listed batches due to reduced potency of the active ingredient

  • Alert type: Drug alert: company-led
  • Issued: 11 August 2016

• Furosemide-Claris 20mg/2ml Injection - AUST R 148003, intended for the Australian market (CLDA (16)A/04)

  Claris Lifesciences UK Ltd are asking pharmacists and wholesalers to check packs of Furosemide-Claris 20mg/2ml Injection (Marketing Authorisation number AUST R 148003) as they have been inadvertently distributed in the UK and are intended for the Australian market.

  • Alert type: Drug alert: company-led
  • Issued: 10 August 2016

• Class 2 medicines recall: Respontin Nebules 250micrograms/1ml & Respontin Nebules 500micrograms/2ml (Ipratropium Bromide)

  Action within 48 hours: Glaxo Wellcome UK Ltd is recalling 4 batches of Respontin Nebules due to out of specification results for impurities obtained during routine stability testing (EL (16)A/10)

  • Alert type: Drug alert
  • Issued: 10 August 2016

• Home use blood glucose monitoring system: TRUEresult and TRUEtrack blood glucose test strips – risk of false low blood glucose results.

  Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia. This Alert refers to different blood glucose test strips to those covered by MDA/2016/009R.

  • Alert type: Medical device alert
  • Issued: 10 August 2016

• Field Safety Notices - 1 - 5 August 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 1 - 5 August 2016

  • Alert type: Field safety notice
  • Issued: 8 August 2016

• NuTRIflex Lipid special 1875ml PL 03551/0031 (Batch number 160338052)

  B Braun Medical Ltd is recalling the above batch as a precautionary measure because the Company has received isolated reports of patient reactions (fever, shivering) associated with administration of the batch.

  • Alert type: Drug alert: company-led
  • Issued: 8 April 2016

• SerenoCem Granules - risk of bone reabsorbtion around granules

  Manufactured by Corinthian Surgical Ltd - risk of bone reabsorbtion around granules implanted in the middle ear (MDA/2016/013)

  • Alert type: Medical device alert
  • Issued: 4 August 2016

• VentStar Oxylog3000F (P) 190 Disposable paediatric ventilation circuit for Oxylog 3000 and Oxylog 3000 plus ventilators – risk of rebreathing exhaled gases

  Manufactured by Draeger Medical – Return ventilation circuits manufactured up to and including March 2016 as they may leak at the check valve.

  • Alert type: Medical device alert
  • Issued: 3 August 2016

• Babytherm® 8004/8010 Infant Warmer, manufactured by Drägerwerk AG & Co – risk of fire

  In skin-temperature control mode, if the temperature sensor is not connected or detaches from the patient, the heating element may overheat causing particles to detach; potentially leading to fire and patient harm or death.

  • Alert type: Medical device alert
  • Issued: 2 August 2016

• Field Safety Notices - 25 July - 29 July 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 25 - 29 July 2016

  • Alert type: Field safety notice
  • Issued: 1 August 2016

• RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette – devices may give incorrect results that could lead to a missed diagnosis.

  Manufactured by Hangzhou Biotest Biotech Co Ltd: certain lots of these devices may give an incorrect false negative or false positive result when testing for HIV, HCV and HBV. These are point of care tests intended for use ONLY in professional clinical settings.

  • Alert type: Medical device alert
  • Issued: 26 July 2016

• Field Safety Notices - 18 July - 22 July 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 18 - 22 July 2016

  • Alert type: Field safety notice
  • Issued: 25 July 2016

• Medical device alerts archived in July 2016

  A list of all medical device alerts that were archived in July 2016.

  • Alert type: Medical device alert
  • Issued: 25 July 2016

• Field Safety Notices - 11 July - 15 July 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 11 - 15 July 2016

  • Alert type: Field safety notice
  • Issued: 18 July 2016

• Field Safety Notices - 4 July - 8 July 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 4 - 8 July 2016

  • Alert type: Field safety notice
  • Issued: 11 July 2016

• Field Safety Notices - 27 June - 1 July 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June - 1 July 2016

  • Alert type: Field safety notice
  • Issued: 4 July 2016

• Reissue: Nipro Diagnostics TRUEyou blood glucose test strips - risk of false low blood glucose results in some batches

  Reissued - manufacturer's telephone number amended: (Nipro Diagnostics) TRUEyou blood glucose test strips - certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia (MDA/2016/009R)

  • Alert type: Medical device alert
  • Issued: 30 June 2016

• Field Safety Notices - 20 - 24 June 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 20 - 24 June 2016

  • Alert type: Field safety notice
  • Issued: 27 June 2016

• Siemens ADVIA Chemistry and Dimension/Dimension Vista products – risk of false low results due to interference with N-acetylcysteine

  False low results may occur in a range of clinical chemistry tests in specimens drawn from patients treated with N-acetylcysteine (NAC) due to the interference with specific assays utilised by Siemens ADVIA instruments.

  • Alert type: Medical device alert
  • Issued: 22 June 2016

• Four Bipolar QuickSite and QuickFlex lead models – risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation

  Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.

  • Alert type: Medical device alert
  • Issued: 21 June 2012

• Field Safety Notices - 13 - 17 June 2016

  List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2016

  • Alert type: Field safety notice
  • Issued: 20 May 2016

• Pemetrexed 25mg/ml Concentrate for solution for Infusion - particulates in small number of vials

  Caduceus Pharma Ltd., Pemetrexed 25mg/ml Concentrate for solution for Infusion: caution in use after particulates identified in a small number of vials (EL (16)A/09)

  • Alert type: Drug alert
  • Issued: 16 June 2016

• Class 2 medicines recall: Medikinet XL 20mg modified-release capsules (methylphenidate hydrochloride)

  Action within 48 hours: B&S Healthcare are recalling two batches of parallel imported Medikinet XL 20mg modified-release capsules that have been incorrectly repackaged in 30mg cartons. (EL (16)A/08)

  • Alert type: Drug alert
  • Issued: 14 June 2016

• Field Safety Notices - 6 - 10 June 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 June 2016

  • Alert type: Field safety notice
  • Issued: 11 June 2016

• Ikervis 1 mg/ml eye drops, emulsion (ciclosporin) - micro particles of active ingredient

  (Santen UK Ltd) Two batches of Ikervis 1 mg/ml eye drops, emulsion (30 single dose containers) (ciclosporin), are being recalled because micro particles of the active ingredient were found in stability test samples (EL(16)A/07)

  • Alert type: Drug alert
  • Issued: 7 June 2016

• Field Safety Notices - 30 May - 3 June 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May - 3 June 2016

  • Alert type: Field safety notice
  • Issued: 6 June 2016

• Field Safety Notices - 23 - 27 May 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 May 2016

  • Alert type: Field safety notice
  • Issued: 1 June 2016

• Epistatus 10mg in 1ml Oromucosal Solution - fault with neck adaptor

  (Special Products Ltd) A batch of Epistatus 10mg in 1ml Oromucosal Solution is being recalled due to the wrong size of neck adaptor in some bottles (EL (16)A/06)

  • Alert type: Drug alert
  • Issued: 25 May 2016

• Paclitaxel 6mg/ml concentrate for solution for infusion; 100mg in 16.7ml - exterior of vials potentially contaminated with Methotrexate

  (Hospira UK Limited) Paclitaxel 6mg/ml concentrate for solution for infusion; 100mg in 16.7ml - risk of the exterior of vials contaminated with Methotrexate (EL (16)A/05)

  • Alert type: Drug alert
  • Issued: 24 May 2016

• CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion

  All devices with an expiration date on or before 31 March 2021 are at risk of under-infusing so we advise users to undertake a risk assessment before using them. (MDA/2016/006)

  • Alert type: Medical device alert
  • Issued: 24 May 2016

• Field safety notices - 16 May - 20 May 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 May 2016

  • Alert type: Field safety notice
  • Issued: 23 May 2016

• Field safety notices - 9 May - 13 May 2016

  Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 May 2016

  • Alert type: Field safety notice
  • Issued: 16 May 2016

• Accu-Chek® Insight insulin pump system, manufactured by Roche Diabetes Care – risk of inappropriate treatment

  Risk of a hypoglycaemic event if users misinterpret maintenance message ‘M-83 pump not able to complete task’.

  • Alert type: Medical device alert
  • Medical specialism: General practice
  • Issued: 12 May 2016

• Field safety notices - 2 May - 6 May 2016

  List of field safety notices (FSNs) from medical device manufacturers from 2 May to 6 May 2016

  • Alert type: Field safety notice
  • Issued: 9 May 2016

• Aventis Pharma Limited trading as Sanofi Rifadin 600mg Infusion

  Sanofi is recalling the A5545 batch of Rifadin because an investigation of out of trend results indicated that it was contaminated with chilled water circulating in the jacket of the reactor during manufacture. (EL(16)A/04)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 6 May 2016

• Field safety notices - 25 April to 29 April 2016

  List of field safety notices (FSNs) from medical device manufacturers from 25 April to 29 April 2016

  • Alert type: Field safety notice
  • Issued: 3 May 2016

• Crestor 5mg Tablets Parallel Imported by BR Lewis Pharmaceuticals Ltd (Originator name Provisacor) –rogue blister and carton

  Potentially a rogue blister and carton may be present in a batch of Crestor 5mg Tablets Parallel Imported by BR Lewis Pharmaceuticals Ltd (Originator name Provisacor) – Class 4 Caution in Use. (EL (16)A/03)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 28 April 2016

• Field safety notices - 18 April to 22 April 2016

  List of field safety notices (FSNs) from medical device manufacturers from 18 April to 22 April 2016

  • Alert type: Field safety notice
  • Issued: 25 April 2016

• Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80mg per 4ml EU/1/95/002/004 (CLDA (16)A/02)

  Sanofi are recalling the listed batches of Taxotere (Docetaxel) Concentrate due to a production fault potentially leading to an increase in the concentration of Docetaxel in the solution.

  • Alert type: Drug alert: company-led
  • Issued: 20 April 2016

• Field safety notices - 11 April to 15 April 2016

  List of field safety notices (FSNs) from medical device manufacturers from 11 April to 15 April 2016

  • Alert type: Field safety notice
  • Issued: 18 April 2016

• Medical device alerts archived in March 2016

  A list of all medical device alerts that were archived in March 2016.

  • Alert type: Medical device alert
  • Issued: 14 April 2016

• Field safety notices - 4 April to 8 April 2016

  List of field safety notices (FSNs) from medical device manufacturers from 4 April to 8 April 2016

  • Alert type: Field safety notice
  • Issued: 11 April 2016

• Field safety notice - 28 March to 01 April

  List of field safety notices (FSNs) from medical device manufacturers from 28 March to 01 April.

  • Alert type: Field safety notice
  • Issued: 4 April 2016

• Field safety notices - 21 March to 25 March 2016

  List of field safety notices (FSNs) from medical device manufacturers from 21 March to 25 March 2016.

  • Alert type: Field safety notice
  • Issued: 29 March 2016

• Estradiol immunoassays – interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results

  Manufactured by Siemens Healthcare Diagnostics Inc. / Siemens Healthcare Diagnostics Ltd and Roche Diagnostics GmbH- assay interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results. Both Siemens and Roche have issued field safety notices (FSNs) highlighting this issue.

  • Alert type: Medical device alert
  • Medical specialism: Critical care
  • Issued: 24 March 2016

• Field safety notices - 14 March to 18 March 2016

  List of field safety notices (FSNs) from medical device manufacturers from 14 March to 18 March 2016.

  • Alert type: Field safety notice
  • Issued: 21 March 2016

• Field safety notices - 7 March to 11 March 2016

  List of field safety notices (FSNs) from medical device manufacturers from 7 March to 11 March 2016.

  • Alert type: Field safety notice
  • Issued: 14 March 2016

• All ZeniPower mercury-free hearing aid batteries – low risk of batteries exploding during use or if depleted

  Manufactured by Zhuhai Zhi Li Battery Co Ltd – stop using batteries with certain best before dates (MDA/2016/003)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 1 others
  • Issued: 10 March 2016

• Field safety notices - 29 February to 4 March 2016

  List of field safety notices (FSNs) from medical device manufacturers from 29 February to 4 March 2016.

  • Alert type: Field safety notice
  • Issued: 7 March 2016

• Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME).

  CME has recommended the need for protection of these pumps when exposed to direct sunlight. In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with the T34 pumps (MDA/2016/002)

  • Alert type: Medical device alert
  • Medical specialism: Critical care
  • Issued: 2 March 2016

• Maxolon 5mg/ml, solution for injection, 2ml ampoules PL 20072/0051

  AMCo are recalling the listed batches of Maxolon 5mg/ml as the outer carton contains incorrect administration instructions.

  • Alert type: Drug alert
  • Issued: 29 February 2016

• Field safety notices - 22 February to 26 February 2016

  List of field safety notices (FSNs) from medical device manufacturers from 22 February to 26 February 2016

  • Alert type: Field safety notice
  • Issued: 29 February 2016

• Field safety notices - 15 to 19 February 2016

  List of field safety notices (FSNs) from medical device manufacturers from 15 February to 19 February 2016

  • Alert type: Field safety notice
  • Issued: 23 February 2016

• Field safety notices - 8 to 12 February 2016

  List of field safety notices (FSNs) from medical device manufacturers from 8 February to 12 February 2016.

  • Alert type: Field safety notice
  • Issued: 15 February 2016

• Field safety notices - 1 to 5 February 2016

  List of field safety notices (FSNs) from medical device manufacturers from 1 February to 5 February 2016.

  • Alert type: Field safety notice
  • Issued: 8 February 2016

• Class 2 medicines recall: Asda, St John’s Wort, HRI Good Mood and Superdrug St John’s Wort tablets THR 02231/0002

  Action within 48 hours: patient, pharmacy and retail level recall of St John's Wort tablets.

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 8 February 2016

• Field safety notices - 25 to 29 January 2016

  List of field safety notices (FSNs) from medical device manufacturers from 25 January to 29 January 2016.

  • Alert type: Field safety notice
  • Issued: 1 February 2016

• Dotarem Solution for Injection, 15ml Syringe Gadoteric Acid 279.32 mg/ml (equivalent to 0.5mmol/ml) (CLDA) (16)A/01

  Precautionary recall because a glass particle has been identified in one syringe from this batch.

  • Alert type: Drug alert: company-led
  • Issued: 1 February 2016

• Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient

  Manufactured by Unomedical Inc / Convatec Ltd – recall due to a manufacturing fault (MDA/2016/001)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 6 others
  • Issued: 26 January 2016

• Field safety notices - 18 to 22 January 2016

  List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2016.

  • Alert type: Field safety notice
  • Issued: 25 January 2016

• Field safety notices - 11 to 15 January 2016

  List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2016.

  • Alert type: Field safety notice
  • Issued: 18 January 2016

• Field safety notices - 4 January to 8 January 2016

  List of field safety notices (FSNs) from medical device manufacturers from 4 January to 8 January 2016.

  • Alert type: Field safety notice
  • Issued: 11 January 2016

• Field safety notices - 28 December to 1 January 2016

  List of field safety notices (FSNs) from medical device manufacturers from 28 December to 1 January 2016.

  • Alert type: Field safety notice
  • Issued: 4 January 2015

• Field safety notices - 21 to 25 December 2015

  List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 December 2015

  • Alert type: Field safety notice
  • Issued: 29 December 2015

• Syner-KINASE 10,000IU powder for solution for injection or infusion (CLDA (15)A/14)

  Specific batch manufactured by Syner-Medica Ltd is being recalled due to concerns it may go out of specification for potency before it expires.

  • Alert type: Drug alert: company-led
  • Issued: 22 December 2015

• Field safety notices - 14 to 18 December 2015

  List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 December 2015

  • Alert type: Field safety notice
  • Issued: 21 December 2015

• GlucoMen LX Sensor test strips used to monitor blood glucose levels - risk of over-estimation

  Distributed by Menarini Diagnostics UK - if test strips have been exposed to high humidity, the results can be falsely high (MDA/2015/039)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 5 others
  • Issued: 21 December 2015

• Fludarabine 25mg/ml, 1 x 2ml - EBEWE Pharma Ges.m.g.h (CLDA (15) A/13)

  Specific batch distributed by Sandoz Ltd is being recalled due to particulate matter found in samples.

  • Alert type: Drug alert: company-led
  • Medical specialism: Pharmacy
  • Issued: 17 December 2015

• Idarubicin 1mg/ml injection 5 and 10ml - Teva UK Limited (CLDA (15)A/12)

  Teva UK Limited is recalling 2 batches as a precautionary measure after visible particles were found during testing.

  • Alert type: Drug alert: company-led
  • Issued: 17 December 2015

• Medical device alerts archived in December 2015

  A list of all medical device alerts that were archived in December 2015.

  • Alert type: Medical device alert
  • Issued: 16 December 2015

• Specific batches of Omeprazole 20mg gastro-resistant capsules (hard) - capsule shells may be more brittle than normal

  (Zentiva) Pharmacists should quarantine remaining stock and return to original wholesaler (EL (15)A/13)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 16 December 2015

• Field safety notices - 7 to 11 December 2015

  List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 December 2015

  • Alert type: Field safety notice
  • Issued: 14 December 2015

• Cardiac Resynchronization Therapy Pacing (CRT-P) - risk of loss of pacing therapy

  Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 7 others
  • Issued: 9 December 2015

• Genotropin 5.3mg and 12mg powder for solution for injection (GoQuick pre-filled pen) - manufacturing defect of some pens used to administer somatropin

  (Pfizer Limited) Defect found to create the possibility of the dose being set to one extra click beyond the dose selected and indicated in the memory window when the patient turns the dose knob with excessive force (EL (15)A/12)

  • Alert type: Drug alert
  • Issued: 9 December 2015

• Field safety notices - 30 November to 4 December 2015

  List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2015

  • Alert type: Field safety notice
  • Issued: 7 December 2015

• Mitoxantrone 2mg/ml Concentrate for Solution for Infusion - Hospira UK Limited

  Hospira UK Limited is recalling 2 specific batches after atypical results for impurities were identified during routine testing.

  • Alert type: Drug alert: company-led
  • Issued: 7 December 2015

• Pioglitazone Accord 30mg Tablets - Accord Healthcare Limited (CLDA (15)A/10)

  Accord Healthcare Limited is recalling a specific batch which has inadvertently been distributed in the UK, because it is labelled for the Portuguese market.

  • Alert type: Drug alert: company-led
  • Issued: 3 December 2015

• Field safety notices - 23 to 27 November 2015

  List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 2015

  • Alert type: Field safety notice
  • Issued: 30 November 2015

• Cernevit powder for solution for injection or infusion - Baxter Healthcare Ltd (CDLA (15)A/09)

  Baxter is recalling a batch of Cernevit powder for solution for injection or infusion as a precautionary measure after receiving 2 complaints of glass particles in vials.

  • Alert type: Drug alert: company-led
  • Issued: 26 November 2015

• Field safety notices - 16 to 20 November 2015

  List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2015

  • Alert type: Field safety notice
  • Issued: 23 November 2015

• Sapphire multi-therapy and epidural pumps – update to instructions for use

  Manufactured by Q Core Medical, distributed in the UK by Hospira – update to instructions for use regarding fluctuations in flow rate accuracy after potential over-infusion of epidural infusions - MDA/2015/037

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 7 others
  • Issued: 18 November 2015

• Field safety notices - 9 to 13 November 2015

  List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 November 2015.

  • Alert type: Field safety notice
  • Issued: 16 November 2015

• Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection

  Do not use for treating neonates and infants below one year old - drug alert EL (14)A/09 issued in June 2014 still stands (EL(15)A/11)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 10 November 2015

• Primidone SERB 50mg tablets - error on the carton

  (Laboratoire SERB) EAN barcode is incorrect – when scanned, it identifies the product as Primidone SERB 250mg tablets not 50mg tablets (EL (15)A/10)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 9 November 2015

• Field safety notices - 2 to 6 November 2015

  List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 November 2015.

  • Alert type: Field safety notice
  • Issued: 9 November 2015

• Field safety notices - 26 to 30 October 2015

  List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2015.

  • Alert type: Field safety notice
  • Issued: 30 October 2015

• All batches of Marcain Polyamp Steripack 0.5% (bupivacaine hydrochloride) - error on carton and ampoule label about administration

  (AstraZeneca UK Limited) This presentation cannot be administered by intra-articular means as it states on the carton and ampoule label on all batches released since December 2012 (EL(15)A/09)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 29 October 2015

• Field safety notices - 19 to 23 October 2015

  List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2015.

  • Alert type: Field safety notice
  • Issued: 23 October 2015

• Bravelle 75IU powder for solution for injection - Ferring Pharmaceuticals Limited (CLDA (15)A/08) - 22 October 2015

  Ferring Pharmaceuticals Limited is recalling all batches of Bravelle 75IU powder for solution for injection on the UK market.

  • Alert type: Drug alert: company-led
  • Issued: 22 October 2015

• Field safety notices - 12 to 16 October 2015

  List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 2015.

  • Alert type: Field safety notice
  • Issued: 16 October 2015

• Testicular implants and inflatable vaginal stents – temporary suspension of the CE certificate

  Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda - MDA/2015/036

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery and 5 others
  • Issued: 15 October 2015

• Field safety notices - 5 to 9 October 2015

  List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 October 2015.

  • Alert type: Field safety notice
  • Issued: 9 October 2015

• Field safety notices - 28 September to 2 October 2015

  List of field safety notices (FSNs) from medical device manufacturers from 28 September to 2 October 2015.

  • Alert type: Field safety notice
  • Issued: 2 October 2015

• Medical device alerts archived in September 2015

  A list of all medical device alerts that were archived in September 2015.

  • Alert type: Medical device alert
  • Issued: 1 October 2015

• Enteral syringe pumps P500, P700 and P900 - recall due to invalid CE marking

  Manufactured by Medicina Ltd - the safety and performance of these devices have not been properly evaluated (MDA/2015/035)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 29 September 2015

• Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda - temporary suspension of the CE certificate

  Suspension due to particles found on some devices (MDA/2015/034)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery and 6 others
  • Issued: 25 September 2015

• Field safety notices - 21 to 25 September 2015

  List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 September 2015.

  • Alert type: Field safety notice
  • Issued: 25 September 2015

• Lacri-Lube Eye Ointment - small black particles on or around the nozzle of the tube

  (Allergan Limited) Small number of complaints have been received about small black particles found on or around the nozzle of the tube (EL (15)A/08).

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 21 September 2015

• Field safety notices - 14 to 18 September 2015

  List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 September 2015.

  • Alert type: Field safety notice
  • Issued: 18 September 2015

• Topotecan Medac 1mg/ml concentrate for solution for infusion, 1x4ml - Medac GmbH - CLDA (15)A/07 - 18 September 2015

  Recalls of medicines issued by manufacturers.

  • Alert type: Drug alert: company-led
  • Issued: 18 September 2015

• Field safety notices - 7 to 11 September 2015

  List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2015.

  • Alert type: Field safety notice
  • Issued: 11 September 2015

• Field safety notices - 31 August to 4 September 2015

  List of field safety notices (FSNs) from medical device manufacturers from 31 August to 4 September 2015.

  • Alert type: Field safety notice
  • Issued: 4 September 2015

• Field safety notices - 24 to 28 August 2015

  List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 August 2015.

  • Alert type: Field safety notice
  • Issued: 28 August 2015

• Sterile electrosurgical forceps and electrodes - Some devices may not be sterile

  (Zethon Limited and Ross Electro Medical Limited) Recall of specific batches (MDA/2015/033)

  • Alert type: Medical device alert
  • Medical specialism: General surgery and 4 others
  • Issued: 26 August 2015

• Charging base for surgical hair clippers - recall of specific lots due to risk of fire

  (Medline Industries) Risk of fire in oxygen-rich environment if defective charging base overheats (MDA/2015/032)

  • Alert type: Medical device alert
  • Medical specialism: Theatre practitioners
  • Issued: 25 August 2015

• Bactroban 2% nasal ointment 3g/ Bactroban 2% cream 15g - Beecham Group plc trading as GlaxoSmithKline UK (CLDA (15)A/06) - 24 August 2015

  Beecham Group plc trading as GlaxoSmithKline UK is recalling specific batches of Bactroban 2% Nasal Ointment 3g and Bactroban 2% Cream 15g.

  • Alert type: Drug alert: company-led
  • Issued: 24 August 2015

• Field safety notices - 17 to 21 August 2015

  List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 August 2015.

  • Alert type: Field safety notice
  • Issued: 21 August 2015

• Accu-Chek mobile meter and Accu-Chek mobile test cassette - risk of falsely high readings if testing procedure is not followed

  (Roche Diabetes Care) Home-use blood glucose monitoring system - if patients do not follow specific testing procedure they may take insulin when they don't need it (MDA/2015/031)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 4 others
  • Issued: 18 August 2015

• Field safety notices - 10 to 14 August 2015

  List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 August 2015.

  • Alert type: Field safety notice
  • Issued: 14 August 2015

• Medical device alerts archived in July 2015

  A list of all medical device alerts that were archived in July 2015.

  • Alert type: Medical device alert
  • Issued: 10 August 2015

• Pregabalin 75mg capsules - incorrect strength printed in one area of foil blister pack

  (Teva UK Limited) 25mg has been incorrectly printed in one position of the affected foil packs however is correct in other positions (EL(15)A/07).

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 12 August 2015

• Field safety notices - 3 to 7 August 2015

  List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 August 2015.

  • Alert type: Field safety notice
  • Issued: 7 August 2015

• Shiley™ neonatal and paediatric tracheostomy tubes - recall of specific affected products

  (Medtronic - previously Covidien) Shiley NEF/NCF/PEF/PCF/PELF/PLCF tracheostomy tubes are being recalled, as some patients experience breathing difficulties when changing to these earlier models of tube from current tubes (MDA/2015/030)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 2 others
  • Issued: 5 August 2015

• All Accu-Chek® Insight insulin pumps - risk of hyperglycaemia from rapid pump battery depletion or unexpected shut down

  (Roche Diabetes Care) Advice from manufacturer to users about the correct battery specification and appropriate pump settings (MDA/2015/029)

  • Alert type: Medical device alert
  • Medical specialism: General practice
  • Issued: 4 August 2015

• Automatically retracting safety syringes including insulin syringes by Medicina Ltd - recall

  (Medicina Ltd) Risk of needle stick injury as they may not automatically retract and the shelf life stated on the devices is incorrect, compromising its sterility (MDA/2015/028)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 4 others
  • Issued: 4 August 2015

• Field safety notices - 27 to 31 July 2015

  List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 July 2015.

  • Alert type: Field safety notice
  • Issued: 31 July 2015

• Chirocaine 5mg/ml solution for injection/concentrate - Abbvie Limited - CLDA (15)A/05 - 30 July 2015

  Recalls of medicines issued by manufacturers.

  • Alert type: Drug alert: company-led
  • Issued: 30 July 2015

• Field safety notices - 20 to 24 July 2015

  List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 July 2015.

  • Alert type: Field safety notice
  • Issued: 24 July 2015

• Steel cannula infusion sets - risk of needle breaking in use

  (Unomedical a/s) May cause leakage of medication and require surgical intervention to remove the needle (MDA/2015/027)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 2 others
  • Issued: 23 July 2015

• Haemodialysis CRIT-LINE® blood chamber with product code CL10021021 - recall due to risk of blood loss

  (Fresenius USA Manufacturing Inc. / Hemametrics) Recall of all lots due to risk of blood loss caused by leakage at the blood chamber connection (MDA/2015/026)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 2 others
  • Issued: 21 July 2015

• Field safety notices - 13 to 17 July 2015

  List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 July 2015.

  • Alert type: Field safety notice
  • Issued: 17 July 2015

• Propofol 10mg/ml (1%) Emulsion for Injection/Infusion 50ml presentation - incorrect colour identifying volume on package

  (Uab Norameda) distributor Peckforton Pharmaceuticals Limited has identified an error on the presentation of the 50ml carton - the coloured band on the package should be purple not pink although text is correct (EL(15)A/06).

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 16 July 2015

• Field safety notices - 6 to 13 July 2015

  List of field safety notices (FSNs) from medical device manufacturers from 6 to 13 July 2015.

  • Alert type: Field safety notice
  • Issued: 13 July 2015

• TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer - risk of serious burn

  (CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 4 others
  • Issued: 6 July 2015

• Field safety notices - 29 June to 3 July 2015

  List of field safety notices (FSNs) from medical device manufacturers from 29 June to 3 July 2015.

  • Alert type: Field safety notice
  • Issued: 3 July 2015

• Xenidate XL 36mg prolonged-release tablets (methylphenidate hydrochloride) - incorrect number of tablets in packs from a specific batch

  (Generics (UK) Limited, trading as Mylan UK) A small number of packs from a specific batch may have an over count or under count of one tablet (EL (15)A/05).

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 29 June 2015

• Field safety notices - 22 to 26 June 2015

  List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 June 2015.

  • Alert type: Field safety notice
  • Issued: 26 June 2015

• Metal-on-metal (MoM) hip replacements - guidance on implantation and patient management

  (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 7 others
  • Issued: 25 June 2015

• Kent and Ascot baths with transfer seats and shepherd's crook/ shower pole fitted - risk of serious injury

  (Care in Bathing Ltd) Seat may detach from bath causing occupant to fall and be seriously injured (MDA/2015/023)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 1 others
  • Issued: 23 June 2012

• Field safety notices - 15 to 19 June 2015

  List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 2015.

  • Alert type: Field safety notice
  • Issued: 19 June 2015

• Field safety notices - 8 to 12 June 2015

  List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 June 2015.

  • Alert type: Field safety notice
  • Issued: 12 June 2015

• Heater-cooler devices used in cardiac surgery - risk of infection with Mycobacterium species

  (All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines.

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 4 others
  • Issued: 11 June 2015

• Medical device alerts archived in May 2015

  A list of all medical device alerts that were archived in May 2015.

  • Alert type: Medical device alert
  • Issued: 9 June 2015

• Field safety notices - 1 to 5 June 2015

  List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 June 2015.

  • Alert type: Field safety notice
  • Issued: 5 June 2015

• Field safety notices - 25 to 29 May 2015

  List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 May 2015.

  • Alert type: Field safety notice
  • Issued: 29 May 2015

• Field safety notices - 18 to 22 May 2015

  List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 2015.

  • Alert type: Field safety notice
  • Issued: 22 May 2015

• Field safety notices - 11 to 15 May 2015

  List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 2015.

  • Alert type: Field safety notice
  • Issued: 15 May 2015

• Field safety notices - 5 to 8 May 2015

  List of field safety notices (FSNs) from medical device manufacturers from 5 to 8 May 2015.

  • Alert type: Field safety notice
  • Issued: 8 May 2015

• Tramadol 50mg capsules - risk of fungal contamination

  (RelonChem Ltd/ Kent Pharmaceuticals) All unexpired batches of 50mg Tramadol capsules are being recalled due to the risk of fungal contamination.

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 6 May 2015

• Field safety notices - 27 April to 01 May 2015

  List of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 2015.

  • Alert type: Field safety notice
  • Issued: 1 May 2015

• All Birdie mobile hoists (lifters) manufactured by Invacare - change to the design of the carabiner used to hold the spreader bar in place

  (Invacare Limited) Change to the design of the carabiner and an update to the instructions for use. (MDA/2015/019)

  • Alert type: Medical device alert
  • Issued: 28 April 2015

• Field safety notices - 20 to 24 April 2015

  List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 2015.

  • Alert type: Field safety notice
  • Issued: 24 April 2015

• Exocin 3mg/ml eye drops - recall of Danish language packs

  (Allergan UK Limited) Specific batch including a Danish language pack was shipped to the UK in error.

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 23 April 2015

• All posture or safety belts fitted to supportive seating, wheelchairs, hoists and bathroom equipment - risk of serious injury or death

  Risk of serious injury or death of the person using a posture or safety belt that isn't fitted or adjusted properly. (MDA/2015/018)

  • Alert type: Medical device alert
  • Issued: 21 April 2015

• Field safety notices - 13 to 17 April 2015

  List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 2015.

  • Alert type: Field safety notice
  • Issued: 17 April 2015

• Field safety notices - 7 to 10 April 2015

  List of field safety notices (FSNs) from medical device manufacturers from 7 to 10 April 2015.

  • Alert type: Field safety notice
  • Issued: 10 April 2015

• Field safety notices - 30 to 03 April 2015

  List of field safety notices (FSNs) from medical device manufacturers from 30 to 3 April 2015.

  • Alert type: Field safety notice
  • Issued: 3 April 2015

• Clexane© 40mg (enoxaparin sodium) - Sanofi - CLDA (15)A/04 - 1 April 2015

  Beecham Group plc trading as GlaxoSmithKline UK is recalling specific batches of Bactroban 2% Nasal Ointment 3g and Bactroban 2% Cream 15g.

  • Alert type: Drug alert: company-led
  • Issued: 1 April 2015

• Defect with Epilim/ sodium valproate gastro-resistant tablets - some batches have an odour

  (Aventis Pharma Limited and Winthrop Pharmaceuticals UK Limited) The smell associated with some batches is said to be a result of the foil packaging, but patients should continue taking their medicine. (EL (15)A/02)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 30 March 2015

• Field safety notices - 23 to 27 March 2015

  List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 2015.

  • Alert type: Field safety notice
  • Issued: 27 March 2015

• Field safety notices - 16 to 20 March 2015

  List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 2015.

  • Alert type: Field safety notice
  • Issued: 20 March 2015

• INRatio® and INRatio®2 PT/INR coagulation monitor and test strips used at home/ point of care - risk of low blood coagulation results

  (Alere) Risk of low blood coagulation results when used by people with certain medical conditions, which can lead to taking the wrong dose of anti-coagulation medicine. (MDA/2015/012)

  • Alert type: Medical device alert
  • Medical specialism: Haematology and oncology and 1 others
  • Issued: 19 March 2015

• Vitaros 3mg/g cream - Takeda UK Ltd - CLDA (15)A/3 - 17 March 2015

  Takeda UK Ltd is recalling a specific batch of Vitaros 3mg/g cream 4 x 100mg.

  • Alert type: Drug alert: company-led
  • Issued: 17 March 2015

• Rienso 30mg/ml solution for infusion - Takeda UK Ltd - CLDA (15)A/02 - 16 March 2015

  Takeda UK Ltd is recalling specific batches of Rienso 30mg/ml solution for infusion (Ferumoxytol).

  • Alert type: Drug alert: company-led
  • Issued: 16 March 2015

• Field safety notices - 9 to 13 March 2015

  List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 March 2015.

  • Alert type: Field safety notice
  • Issued: 13 March 2015

• PadPro and R2 multifunction electrodes - risk of delay to shock

  (Conmed) Risk of delay to shock as specific electrodes manufactured by Conmed are now incompatible with some models of Philips defibrillators (MDA/2015/010)

  • Alert type: Medical device alert
  • Issued: 12 March 2015

• Field safety notices 2 to 6 March 2015

  List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2015.

  • Alert type: Field safety notice
  • Issued: 6 March 2015

• Field safety notices - 23 to 27 February 2015

  List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 February 2015.

  • Alert type: Field safety notice
  • Issued: 27 February 2015

• Consent decree for medical devices supplied by Atrium Medical (Maquet)

  (Atrium Medical subsidiary of Maquet) Guidance for healthcare professionals who have received a Food and Drug Administration (FDA) consent decree from Maquet about its subsidiary Atrium Medical. (MDA/2015/006)

  • Alert type: Medical device alert
  • Issued: 20 February 2015

• Field safety notices - 16 to 20 February 2015

  List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 February 2015.

  • Alert type: Field safety notice
  • Issued: 20 February 2015

• CEM™ nosecones for use with CUSA® Excel/Excel+ ultrasonic aspirator - risk of burns

  (Integra LifeSciences) Risk of burns to user if the blue COAG button on the CUSA Excel CEM nosecone sticks in the ‘activated’ position. (MDA/2015/005)

  • Alert type: Medical device alert
  • Medical specialism: Theatre practitioners
  • Issued: 18 February 2015

• Field safety notices - 9 to 13 February 2015

  List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 February 2015.

  • Alert type: Field safety notice
  • Issued: 13 February 2015

• Field safety notices - 2 to 6 February 2015

  List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 February 2015.

  • Alert type: Field safety notice
  • Issued: 6 February 2015

• Field safety notices - 26 to 30 January 2015

  List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 January 2015.

  • Alert type: Field safety notice
  • Issued: 30 January 2015

• Field safety notices - 19 to 23 January 2015

  List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 January 2015.

  • Alert type: Field safety notice
  • Issued: 23 January 2015

• Field safety notices - 12 to 16 January 2015

  List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 January 2015.

  • Alert type: Field safety notice
  • Issued: 16 January 2015

• Oral diclofenac presentations with legal status ‘P’ – reclassified to POM

  (Novartis Consumer Health UK Limited and Actavis Group PTC EHF): Product reclassified from P to POM due to safety concerns – class 2 action within 48 hours (EL (15)A/01)

  • Alert type: Drug alert
  • Medical specialism: General practice and 2 others
  • Issued: 14 January 2015

• Ebixa 5mg/pump actuation 50ml and 100ml bottle - fault with some of the pump devices

  (Lundbeck Limited) May result in suboptimal dosage of the product - class 2 action within 48 hours. (EL (14)A/19)

  • Alert type: Drug alert
  • Issued: 18 December 2014

• Mains power lead used with Omnifuse syringe pumps (part number 0151-0651) - quarantine affected leads

  (Smiths Medical International Ltd. - all models) incorrect design of the mains lead causes a risk of interruption or delay in therapy. (MDA/2014/044)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 1 others
  • Issued: 26 November 2014

• Amoxil Vials for injection 500mg and 1g, Augmentin Intravenous 600mg and 1.2g - cracks in vials used for packaging

  (GlaxoSmithKline) Check each vial for cracks by turning upside down and looking for chips, cracks or damage where base meets side wall. (EL (14)A/15)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 15 October 2014

• LIFEPAK® 1000 defibrillator - risk of failure to deliver a shock

  (Physio-Control) Due to unexpected shut down of the defibrillator caused by a battery with very low charge. (MDA/2014/040)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 7 others
  • Issued: 9 October 2014

• TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D) - identify patients affected recently

  (Boston Scientific) Rapid battery depletion leads to risk of loss of therapy. (MDA/2014/039)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 2 others
  • Issued: 7 October 2014

• All medical devices - ensure system is in place to distribute field safety notices (FSNs)

  (All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 21 others
  • Issued: 26 September 2014

• Ellipse™ VR/DR implantable cardioverter defibrillators (ICDs) - potential failure mode

  (St Jude Medical) These defibrillators can delay or reduce the therapy that can be delivered by the ICD.(MDA/2014/035)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 2 others
  • Issued: 16 September 2014

• Motilium 10 10mg Tablets and Motilium Instants10mg – changed to prescription-only medicine

  (McNeil Products Limited) Remaining stocks of the above products should be quarantined - class 2 action within 48 hours. (EL (14)A/14)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 3 September 2014

• Idarubicin 1mg/ml injection 5 & 10 ml - recall

  (Teva UK Limited) red precipitate found during stability testing under cold storage conditions - class 2 action within 48 hours. (EL (14)A/13)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 13 August 2014

• Buccolam Oromucosal Solution - possibility for chemical contamination

  (ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 28 July 2014

• Amoxicillin Sodium 500mg powder for solution for injection - additional reports of injection site reactions in paediatrics and adults

  (Wockhardt UK Ltd) Remaining stock from affected batches should be quarantined and returned to the original supplier for credit - class 2 action within 48 hours. (EL (14)A/11)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 22 July 2014

• Midazolam Buccal Liquid 10mg / 1ml, 5ml - screw caps not been correctly placed

  (Penn Pharma, distributed in Quantum Pharmaceutical livery) May result in evaporation of aqueous component of product and increase in concentration of Midazolam. (EL (14)/A10)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 16 July 2014

• Breast implants - report cases of anaplastic large cell lymphoma (ALCL)

  (All types, makes and models) Report cases in women who have breast implants or who have had them removed. (MDA/2014/027)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery and 3 others
  • Issued: 10 July 2014

• Amoxicillin Sodium 250mg, 500g, & 1mg powder for solution for injection - reports of extravasation and injection site reactions

  (Wockhardt UK Ltd) Should not be used in neonates and infants under 1 year old until further notice. (EL (14)A/09)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 9 July 2014

• Fybogel Hi-Fibre and Fybogel Orange - potential risk of contamination with metal particles

  (Reckitt Benckiser Healthcare (UK) Limited) Remaining stock of batches should be quarantined and returned to original supplier for credit. - class 2 action within 48 hours. (EL (14)A/08)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 19 June 2014

• Clarithromycin 500mg Powder for Solution for Infusion - small particles of white material to be present in individual vials

  (Mylan on behalf of Strides Arcolab International Limited) Remaining stocks of affected batches should be quarantined - class 2 action within 48 hours. (EL (14)A/07)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 18 June 2014

• Vancomycin Powder for Concentrate for Solution for Infusion - small particles of fibre material and glass in individual vials

  (ITH Pharma Ltd) Remaining stocks should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/06)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 12 June 2014

• Lipid Phase only of Parenteral Nutrition - potential contamination with Bacillus cereus

  (ITH Pharma Ltd) Small number of reported cases of bacillus cereus septicaemia affecting neonates - class 1 action now. (EL (14)A/05)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 4 June 2014

• Heated humidifiers used in combination with heated-wire breathing systems - risk of oxygen-fuelled fire

  (Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 2 others
  • Issued: 4 June 2014

• Paradigm ambulatory insulin infusion pumps - risk of hypoglycaemia

  (Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 29 May 2014

• Unicondylar sled knee prosthesis - risk of early wear

  (Waldemar Link GmbH & Company.KG) Consider annual review of patients for up to 5 years after implantation, including X-rays to detect progression of bearing wear. (MDA/2014/018)

  • Alert type: Medical device alert
  • Medical specialism: Theatre practitioners
  • Issued: 28 May 2014

• All Pace Medical Inc temporary pacemakers and pacing system analysers (PSAs) – CE marking suspended

  (Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 3 others
  • Issued: 14 May 2014

• Samaritan® public access defibrillator - may miscalculate the cardiopulmonary resuscitation (CPR) rate

  (HeartSine Technologies) Rescuer may be incorrectly advised by the device to ‘Push Slower’ when CPR rate is actually at an acceptable level. (MDA/2014/014)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 29 April 2014

• Fybogel Orange - risk of contamination with metal particles

  (Reckitt Benckiser Healthcare (UK) Limited) Remaining stock should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/04)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 12 March 2014

• Insulin infusion pump - risk of delay in treatment

  (Roche Diagnostics Ltd) Increased risk that the vibration alarm will not work as a result of a changed component. (MDA/2014/008)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 10 March 2014

• Viread 245 mg film-coated tablets - possible presence of silicone rubber

  (Gilead Sciences Limited) Pharmacists should quarantine any remaining stocks affected batches and return them to the original wholesaler for credi - class 2 action within 48 hours. (EL (14)A/03)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 6 March 2014

• Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 - risk of injury

  (Carestream Health) Risk of injury if joint between scissor arm and bracket fails. (MDA/2014/005)

  • Alert type: Medical device alert
  • Medical specialism: Dentistry
  • Issued: 21 February 2014

• COSOPT preservative-free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container - difficulties with administration

  (Merck Sharp and Dohme) Increase in the number of adverse events and product complaints following introduction of ‘winged’ presentation - class 2 action within 48 hours. (EL (14)A/02)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 17 February 2014

• Counterfeit or non-CE marked dental medical devices

  (All products) Could fail during use with a risk of injury to patient and user. (MDA/2014/004)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery and 2 others
  • Issued: 24 January 2014

• Irbesartan / Hydrochorothiazide Teva 300/12.5mg and 300/25mg film-coated tablets - incorrect dosing instruction in patient information leaflet

  (Teva UK Ltd) Leaflet incorrectly states take 1 or 2 tablets a day. (EL (14)A/01)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 8 January 2014

• OPTEASE® retrievable vena cava filter - risk of serious patient injury

  (Cordis Corporation) Risk from the migration of a wrongly orientated inferior vena cava (IVC) filter. (MDA/2014/001)

  • Alert type: Medical device alert
  • Issued: 2 January 2014

• Irbesartan 300mg film-coated tablets - blisters is incorrectly labelled as Irbesartan 150mg

  (Accord Healthcare Limited) Recipients should quarantine any remaining stock and return it to supplier for credit - class 2 action within 48 hours. (EL (13)A/32)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 23 December 2013

• GemStar docking station for use with specific GemStar infusion pumps - potential for delay in infusion therapy

  (Hospira) May fail to power up or configuration could generate an error code, stopping a running infusion. (MDA/2013/085)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 14 others
  • Issued: 19 December 2013

• Implantable pacemakers - residual longevity overestimated

  (Sorin) Difference between predicted and actual pacemaker battery depletion characteristics. (MDA/2013/084)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 19 December 2013

• Methotrexate 25mg/ml injection - damaged vials

  (Teva UK Limited) Damaged vials so potential for a lack of sterility assurance - class 2 action within 48 hours. (EL (13)A/31)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 17 December 2013

• Tixylix® liquid medicines - small pieces of plastic being found in medicine

  (Novartis Consumer Health UK Ltd) Fault with tamper seal on might result in small pieces of plastic being found in medicine.

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 13 December 2013

• Class 4 drug alert (caution in use): Matrifen 100 micrograms/hour Transdermal Patch, Teva UK Livery - Takeda UK Limited (EL (13)A/29)

  Takeda UK Limited has informed us that there is an error in the text on the pouch for batches of Matrifen 100 micrograms/hour transdermal patches distributed since 25 May 2013 in Teva UK livery.

  • Alert type: Drug alert
  • Issued: 12 December 2013

• Jext 300 and 150 micrograms solution for injection in pre-filled pens - problem with delivery of dosage

  (ALK-Abelló A/S) Potential problem with delivery of dosage following activation of auto injector.

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 9 December 2013

• Class 4 Drug Alert (Caution in Use): 8.4% w/v Sodium Bicarbonate - B. Braun Melsungen AG - PL 03551/0069

  This alert has been issued as B.

  • Alert type: Drug alert
  • Medical specialism: Critical care and 1 others
  • Issued: 5 December 2013

• Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser - CE marking withdrawn

  (Hospira) Use an alternative pump, where available. (MDA/2013/078)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 21 others
  • Issued: 4 November 2013

• Imigran Injection/Subject - syringes may have needles protruding from the needle shield

  (GlaxoSmithKline UK) Remaining stocks of the affected batch should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/26)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 29 October 2013

• NovoMix 30 Penfill 100U/ml, 3ml and NovoMix 30 FlexPen 100U/ml, 3ml – cartridges contain too much or too little insulin in batches

  (Novo Nordisk A/S) Patients who may have received the affected batches should be contacted and asked to check their supply – class 2 action within 48 hours. (EL (13)A/25)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 25 October 2013

• Multiple products by Wockhardt UK Limited – 2nd site certificate withdrawn

  (Morningside Healthcare Limited) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. – class 2 action within 48 hours. (EL (13)A/24)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 17 October 2013

• BD Neoflon IV cannula - risk of delay in treatment

  (Becton Dickinson) Due to increased risk of the catheter buckling during initial puncture of skin. (MDA/2013/074)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff
  • Issued: 10 October 2013

• Natzon 0.4mg Sublingual Tablets - wrong blister packs in cartons

  (Morningside Healthcare Limited) Small number of blisters containing Buprenorphine 8mg Sublingual Tablets packed in cartons labelled Natzon 0.4mg Sublingual Tablets – class 2 action within 48 hours. (EL (13)A/23)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 26 September 2013

• Bydureon 2mg powder and solvent - may contain small number of under-filled vials

  (Eli Lilly Nederland B.V.) Remaining stocks of affected batch should be quarantined and returned to original supplier for credit – class 2 action within 48 hours. (EL (13)A/22)

  • Alert type: Drug alert
  • Issued: 16 September 2013

• HeartStart XL defibrillator/monitor - battery life and capacity test interval reduced

  (Philips) Battery life reduced from 1.5 years to 1 year and capacity test interval reduced from 6 months to 3 months. (MDA/2013/066)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 6 others
  • Issued: 15 August 2013

• Warfarin 3mg tablets - higher than expected levels of degradation

  (Teva UK Limited) Remaining stock should be quarantined and returned to original supplier for credit – class 3 action within 5 days. (EL (13) A/21)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 1 August 2013

• Wheeled and non-wheeled walking frames (all models) - potential for detachment of the wheels and/or inadequately tightened screws

  (Patterson Medical) May cause the user to fall. (MDA/2013/060)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 1 others
  • Issued: 1 August 2013

• Days walking stick (Model 404) - handle can crack

  (Patterson Medical Ltd) May cause the user to fall. (MDA/2013/055R)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 1 others
  • Issued: 24 July 2013

• Multiple products by Wockhardt UK Limited – certificate for manufacturing site withdrawn

  (Wockhardt UK Limited) Remaining stocks of affected batches should be quarantined and returned to original supplier for credit – class 2 action within 48 hours (EL (13)A/19)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 11 July 2013

• HeartStart MRx Monitor/Defibrillator –possible failure to deliver defibrillation therapy

  (Philips Healthcare) May fail to deliver defibrillation therapy in either “Manual Defib”, “AED” or “Sync Cardioversion” mode. (MDA/2013/052)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 4 others
  • Issued: 11 July 2013

• Erythromycin Oral Suspension – manufacturers certificate withdrawn

  (Pinewood Laboratories Limited) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/18)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 11 July 2013

• Biplane cardiovascular X-ray system (Floor Mounted) - risk of interruption in treatment/procedure

  (Philips) Motorised geometry control system will reboot if users attempt simultaneous powered and manual movement of the C-arm. (MDA/2013/045R)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 2 others
  • Issued: 10 July 2013

• Hydroxyethyl starch (HES) products - increased risk of renal dysfunction and mortality

  (B Braun Melsungen AG and Fresenius Kabi Limited) Increased risk of renal dysfunction and mortality in critically ill or septic patients– class 1 action within 48 hours. (EL (13)A/18)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 27 June 2013

• Biplane cardiovascular X-ray system - risk of interruption in treatment/procedure

  (Philips) Table will reboot if users attempt a powered and manual movement at the same time. (MDA/2013/045)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 2 others
  • Issued: 24 June 2013

• Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS - incorrectly etched screw size

  (Synthes GmbH) Could lead to clinical complications including dural injury, bleeding and failure of fracture fixation. (MDA/2013/044)

  • Alert type: Medical device alert
  • Issued: 20 June 2013

• Implantable drug pumps and accessories - risk of drug under- or overdose

  (Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 1 others
  • Issued: 19 June 2013

• AmBisome 50mg Powder for Solution for Infusion - potential lack of sterility assurance

  (Gilead Sciences International Limited) Remaining stocks of affected batches should be quarantined and returned to the original supplier for credit – class 1 action now. (EL (13)A/17)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 18 June 2013

• Ventolin Syrup sugar-free 2mg in 5ml - risk of glass fragments in the bottles

  (Glaxo Wellcome UK Ltd) Source of possible contamination is believed to be sucrose used within this formulation of Questran – potential risk of glass fragments in bottles due to defect identified in very small number of bottles – class 2 action within 48 hours. (EL (13)A/16)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 14 June 2013

• Questran 4g sachet Powder for Oral Suspension - possible contamination with Enterococcus faecium

  (Bristol-Myers Squibb Pharmaceuticals Limited) Source of possible contamination is believed to be sucrose used within this formulation of Questran – class 2 action within 48 hours. (EL (13)A/15)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 3 June 2013

• MICRO-PACE REF 4580 - return to market

  (Pace Medical and distributed in UK by APC Cardiovascular) Ensure continued, heightened vigilance in monitoring. (MDA/2013/036)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 3 others
  • Issued: 31 May 2013

• Paradigm ambulatory insulin infusion pumps - risk of compromised insulin therapy

  (Medtronic) May lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (MDA/2013/035)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 17 May 2013

• Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - risk of inadequate external pacing

  (All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death. (MDA/2013/032)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 3 others
  • Issued: 9 May 2013

• Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of the syringe label

  (Aurum Pharmaceuticals Limited (trading as Martindale Pharma)) Replaces drug alert issued on 29 April 2013 (EL 13(A)13 Rev 1)

  • Alert type: Drug alert
  • Issued: 7 May 2013

• Retrievable inferior vena cava (IVC) filters - serious complications associated with attempted IVC filter retrieval

  (All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model. (MDA/2013/028)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 5 others
  • Issued: 2 May 2013

• Ativan Injection 4mg/ml - glass particles identified

  (Pfizer Limited) Very small number of ampoules containing glass particles identified – class 3 action within 5 days. (EL (13)A/14)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 2 May 2013

• Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of syringe label

  (Aurum Pharmaceuticals Limited (trading as Martindale Pharma)) Pre-filled syringes from affected batches should be used with caution.– class 3 action within 5 days. (EL 13(A)13)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 29 April 2013

• Diazepam 2mg Tablets - does not comply with the required specification

  (Teva UK Limited) results of assays carried out during routine stability studies did not comply with the required specification – class 3 action within 5 days. (EL 13(A)11)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 24 April 2013

• Miacalcic 200 IU Nasal Spray Solution - withdrawn throughout the European Union

  (Novartis Pharmaceuticals UK) Increased risk of malignancies with long -term use of calcitonin – class 2 action within 48 hours. (EL 13(A)11)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 2 April 2013

• Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces

  (All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device. (MDA/2013/019)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 5 others
  • Issued: 27 March 2013

• Acrobat Swing (AC Swing) arm - risk of injury from detachment of the swing arm

  (Ondal) After approximately 7 years of use, the plastic spigot joint of swing arm can fail through fatigue. (MDA/2013/020)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 1 others
  • Issued: 27 March 2013

• GemStar infusion system - risk of over-infusion, low infusion rates or an interruption of infusion

  (Hospira) Due to pump faults. (MDA/2013/016)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 14 others
  • Issued: 26 March 2013

• Oxoid antimicrobial susceptibility testing discs (AST) - presence of non-impregnated or ‘blank’ AST discs

  (Finsbury Orthopaedics Ltd) Could lead to a false indication of antibiotic resistance. (MDA/2013/014)

  • Alert type: Medical device alert
  • Medical specialism: Infection prevention and 1 others
  • Issued: 20 March 2013

• Circadin 2mg prolonged-release tablets – error in patient information leaflet

  (RAD Neurim Pharmaceuticals EEC Limited) Error in batches distributed since 11 February 2013. (EL (13)A/10)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 20 March 2013

• ADEPT® 12/14 modular head hip components - higher than expected revision rate

  (Finsbury Orthopaedics Ltd) Do not implant ADEPT® 12/14 modular head devices. (MDA/2013/010)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 2 others
  • Issued: 12 March 2013

• Cytarabine Injection 100mg/ml (1g/10ml) - potential for crystallisation

  (Hospira UK Limited) Visually inspect vials for particulate matter prior to use and do not use if crystals are found - Class 4 medicines defect information (EL (13)A/09)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 6 March 2013

• Montelukast 5 mg Chewable Tablets - error on the carton

  (Mylan) Carton incorrectly states "For children 2 to 5 years" but patient information leaflet (PIL) correctly states "For children 6 to 14 years" – class 2 action within 48 hours. (EL (13)A/08)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 5 March 2013

• Brochlor 1% w/w Eye Ointment – issue with seal integrity and compromised sterility assurance

  (Sanofi-aventis) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/07)

  • Alert type: Drug alert
  • Issued: 27 February 2013

• GoldenEye 0.15% w/w eye ointment – issue with seal integrity and compromised sterility assurance

  (Cambridge Healthcare Supplies Limited on behalf of Typharm Limited) Remaining stocks of the affected batches should be quarantined and returned to Cambridge Healthcare Supplies Limited – class 2 action within 48 hours. (EL (13)A/06)

  • Alert type: Drug alert
  • Issued: 27 February 2013

• Desloratadine ratiopharm 5mg film-coated tablets - higher than expected levels of impurities detected

  (ratiopharm GmbH) Corrected batch numbers from EL (13)A/04 –class 3 action within 5 days. (EL (13)A/04 Rev 1)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 26 February 2013

• Isoline implantable cardioverter defibrillator (ICD) leads - risk of inappropriate shocking, pacing inhibition or shocking inhibition

  (Hospira) Due to insulation abrasion. (MDA/2013/007)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 21 February 2013

• Infusion pumps: Plum A+ and A+3 family of infusers - risk of interruption in therapy

  (Hospira) If pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (MDA/2013/006)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 4 others
  • Issued: 20 February 2013

• Dexamfetamine Sulphate 5mg Tablets – packs may contain 3 blister strips instead of 2

  (Auden Mckenzie Ltd) Small number may contain 3 blister strips –class 4 caution in use. (EL (13)A/05)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 19 February 2013

• Infusion pumps: Plum A+ single channel infuser systems - risk of interruption in therapy

  (Hospira) Clinical staff failing to hear an audible alarm. (MDA/2013/004)

  • Alert type: Medical device alert
  • Issued: 6 February 2013

• Gygel Contraceptive Jelly – test results did not comply with required specifaction

  (Merck Sharp & Dohme Ltd) Being recalled as a precaution because results of assays for routine stability studies did not comply with required specification class 3 action within 5 days. (EL (13)A/03)

  • Alert type: Drug alert
  • Medical specialism: General practice and 2 others
  • Issued: 29 January 2013

• Tredaptive modified-release tablets - withdrawn throughout the European Union

  (Merck Sharp & Dohme Ltd) Study showed failure to reduce major vascular events and increase in non-fatal serious adverse events – class 2 action within 48 hours. (EL (13)A/02)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 21 January 2013

• Medical oxygen and medical air cylinders filled to 200 atmospheres - may cause damage to other devices

  (Various manufacturers) Damage to devices such as anaesthetic machines, ventilators, incubators, respiratory support and resuscitation equipment. (MDA/2013/002)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 4 others
  • Issued: 14 January 2013

• External pacemaker: MICRO-PACE REF 4580 - temporarily withdrawn from sale

  (Pace Medical and distributed in the UK by APC Cardiovascular) Potential for loss of ventricular output or sensing failure. (MDA/2013/001)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 2 others
  • Issued: 10 January 2013

• Vimpat 150mg Tablets - blister strips are incorrectly labelled

  (OPD Laboratories Limited) Recall as some packs have incorrectly-labelled blister strips – class 2 action within 48 hours. (EL (13)A/01)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 8 January 2013

• Orgaran 750 anti-Xa units solution for injection – incorrect patient information leaflet

  (Merck Sharp & Dohme Limited trading as Organon Laboratories Limited) Technical portion of leaflet aimed at the healthcare professional omitted. (EL (12)A/35)

  • Alert type: Drug alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 28 November 2012

• Samaritan public access defibrillator - risk of failure to deliver therapy

  (HeartSine) may repeatedly turn on and off when not in use, switch off after delivering a single shock or give a premature low battery warning. (MDA/2012/079)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 19 November 2012

• All medical devices and medicinal products containing chlorhexidine - Risk of anaphylactic reaction due to chlorhexidine allergy

  (Various manufacturers) Check labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy. (MDA/2012/075)

  • Alert type: Medical device alert
  • Issued: 25 October 2012

• AlboGraft polyester vascular graft - sales of AlboGraft now permitted in the UK

  (Pace Medical and distributed in the UK by APC Cardiovascular) Grafts should be leak tested prior to use until end of December 2012. (MDA/2012/072)

  • Alert type: Medical device alert
  • Medical specialism: General surgery and 2 others
  • Issued: 18 October 2012

• External pacemaker - risk of under-sensing or output failure when used on patients with epicardial pacing wires

  (Pace Medical and distributed in the UK by APC Cardiovascular) Do not use these pacemakers with epicardial pacing wires until they have undergone 3 upgrades. (MDA/2012/070)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 9 October 2012

• Typhim Vi - Typhoid Polysaccharide Vaccine - antigen levels below required specification

  (Sanofi Pasteur MSD) Some batches may have antigen levels below required specification – class 2 action within 38 hours. (EL (12)A/33)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 8 October 2012

• Diflucan powder for oral suspension (10 mg/ml and 40 mg/ml) - amended labels and patient information leaflet

  (Pfizer Limited) Clarification of confusion resulting from amended labels and patient information leaflet – class 4 caution in use. (EL (12)A/31)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 20 September 2012

• Silicone tracheostomy tubes - eyelets of silicone tracheostomy tubes damaged by holder

  (Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 6 others
  • Issued: 11 September 2012

• Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads Manufactured by St Jude Medical (MDA/2012/061)

  This Medical Device Alert has been issued as there is a risk of inappropriate shock or therapy failure due to wear of lead insulation when using implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical.

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 10 September 2012

• Epistatus, Midazolam 10mg in 1ml Buccal Liquid x 5ml - packs containing new syringes to be distributed

  (Special Products Ltd) Packs containing the new syringe to be distributed from September 2012 – class 4 caution in use - class 4 caution in use. (EL (12)A/26)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 23 August 2012

• Zovirax Suspension 200mg/5ml - incorrect dosing instructions

  GlaxoSmithKline UK are recalling multiple batches of 125ml bottles of the above product.

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 22 August 2012

• Paracetamol Tablets 500mg - incorrect blister foil

  (Actavis UK Ltd) Use of incorrect blister foil which fails to meet the specification for child resistancen – class 2 action within 48 hours. (EL (12)A/24)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 13 August 2012

• Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) – failure to appropriately decontaminate

  (Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 9 others
  • Issued: 28 June 2012

• Metal-on-metal (MoM) hip replacements - updated advice with patient follow ups

  (All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements. (MDA/2012/036)

  • Alert type: Medical device alert
  • Medical specialism: Orthopaedics and 4 others
  • Issued: 25 June 2012

• Anaesthetic machines and associated devices - reports about what check failures cause

  (All manufacturers) reports say that failure to check anaesthetic machines and or the breathing system is a major factor in many anaesthetic misadventures, including some that have resulted in hypoxic brain damage or death.(MDA/2012/031)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 2 others
  • Issued: 31 May 2012

• Anapen 500mcg, 300mcg and Junior 150mcg/0.3ml solution for injection in a pre-filled syringe

  (Lincoln Medical Limited) Potential problem could result in a failure to deliver any adrenaline at all in an emergency situation – class 2 action within 48 hours. (EL (12)A/20)

  • Alert type: Drug alert
  • Medical specialism: General practice and 1 others
  • Issued: 23 May 2012

• Levothyroxine 100mcg tablets - recall of Teva UK and Numark branded product

  (Teva UK and Numark liveries) Remaining stock should be returned to wholesaler for credit – class 3 action within 5 days. (EL (12)A/13)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 9 May 2012

• Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation - diagnosis of breast cancer difficult in some cases

  (Q-Med AB - a Galderma division) problem with use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult. (MDA/2012/022)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery and 3 others
  • Issued: 25 April 2012

• Oral swabs with a foam head - heads may detach during use

  (All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients. (MDA/2012/020)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 4 others
  • Issued: 12 April 2012

• Rabipur - potential problem packaging of syringes

  (Novartis Vaccines and Diagnostics GmbH) Potential problem with packaging of the syringes supplied with specific batches of Rabipur – class 4 caution in use. (EL (12)A/13)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 21 March 2012

• Implantable cardioverter defibrillators (ICD) - risk of loss/ pacing therapy

  (Medtronic) once elective replacement indicator (ERI) is reached there is a risk of loss of ICD/pacing therapy from rapid battery depletion that occurs around 2.5 years after implantation. (MDA/2012/014)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 16 March 2012

• Silicone gel filled breast implants - updated information on filler

  (Poly Implant Prothese (PIP) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler. (MDA/2012/011)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery
  • Issued: 15 March 2012

• Stapler Duet TRS™ universal straight and articulating single use loading units (SULU) - do not use for adult or paediatric thoracic surgery procedures

  (Covidien) reports of serious injuries after use of Stapler Duet TRS™ loading units in the thoracic cavity.(MDA/2012/005)

  • Alert type: Medical device alert
  • Medical specialism: Theatre practitioners and 1 others
  • Issued: 16 February 2012

• Vigantoletten (1000 IU Colecalciferol) Tablets – reminder that tablets contain soya oil

  (Merck Serono) Contraindicated for patients with allergies to soya oil - class 4 caution in use. (EL (14)A/15)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 23 January 2012

• Dekristol (20,000 IU Colecalciferol) Capsules - contain arachis (peanut) oil

  (MIBE GMBH) Contraindicated for patients with allergies to peanut oil - calls 5 caution in use. (EL (12)A/03)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 23 January 2012

• Clopixol Conc Injection (500mg/ml) - cracked ampoules

  (Lundbeck Limited) Reports of cracked ampoules and concerns about guaranteeing sterility – class 2 actions within 48 hours (EL (11)A/33)

  • Alert type: Drug alert
  • Medical specialism: General practice and 1 others
  • Issued: 23 December 2011

• Auxiliary common gas outlet (ACGO) for anaesthetic machine - no fresh gas flow to patient with wrong setting

  (GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 2 others
  • Issued: 1 December 2011

• Xigris 5 mg and 20 mg recall due to risk/benefit concerns

  (Eli Lilly) Recall following clinical trial findings showing lack of efficacy and risk/benefit concerns – class 1 action now. (EL (14)A/15)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 26 October 2011

• Some EnRhythm® and EnRhythm MRI™ implantable pacemakers - software update may trigger unexpected ERI

  (Medtronic) a software update of the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI. (MDA/2011/097)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 28 September 2011

• Reusable laryngoscope handles - inquest found contaminated device caused patient's death

  (All models and manufacturers) MHRA received a report of an inquest that found a patient died after a laryngoscope handle had not been decontaminated appropriately between each patient use. (MDA/2011/096)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 3 others
  • Issued: 27 September 2011

• Nurofen Plus tablets containing rogue blister strips in additional 2 cartons

  (Reckitt Benckiser (UK) Ltd) Recall of all unexpired stock of Nurofen Plus tablets in any pack size – class 1 action now. (EL(11)A/21)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 26 August 2011

• Implantable pulse generators (IPGs) neurostimulators - confirm actions from field safety notice

  (St Jude Medical) manufacturer not received sufficient confirmation of action after a field safety notice was sent out on the faulty battery components that could result loss in ability to communicate with the programmer or recharge in some IPGs. (MDA/2011/079)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 1 others
  • Issued: 13 July 2011

• Headrest attachment to operating tables - confirm actions after receipt of field safety notice

  (Maquet Ltd) manufacturer has not received sufficient confirmation of actions after it sent a field safety notice on safe use of connection fixture 1002.65A0 and 1002.65S0. (MDA/2011/075)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 5 others
  • Issued: 6 July 2011

• Implantable cardioverter defibrillator (ICD) - risks with pacing inhibition

  (Sorin CRM) pacing inhibition causes risk of bradycardia / syncope; also potential association between pacing inhibition and ventricular oversensing if 'PhD' is 'on' and the device is connected to high polarisation defibrillation leads. (MDA/2011/073)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 29 June 2011

• Canesten Pessary - 2 batches have wrong patient information leaflet

  (Bayer Consumer Care Division) Two batches inadvertently placed on the market containing patient information leaflet (PIL) for prescription only medicine (POM) product - class 4 caution in use. (EL(11)A/17)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 21 June 2011

• Needle-free intravenous connectors - incompatibility and risk of infection

  (All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/2011/068)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 5 others
  • Issued: 15 June 2011

• SQ-RX® pulse generator, model 1010 - subcutaneous implantable cardioverter defibrillator (S-ICD) - battery might die early

  (Cameron Health) risk of premature depletion of battery before the 3 nominal months. (MDA/2011/067)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 13 June 2011

• Plum A+ infusion pumps - potential failure

  (Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 3 others
  • Issued: 8 June 2011

• Dual Chamber Pacemakers - confirm actions with manufacturer after receipt of field safety notices

  (Medtronic Ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (Reference: FA507). (MDA/2011/060)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 2 June 2011

• Pacemaker - Reply and Esprit models interrogated with programmer containing software version 2.24 - software anomaly

  (Sorin CRM) field safety notice published after a programmer software anomaly was found that could lead to cardiac instability or unnecessary explant due to inconsistent battery information. (MDA/2011/056)

  • Alert type: Medical device alert
  • Medical specialism: Anaesthetics and 3 others
  • Issued: 25 May 2011

• Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - risk of inappropriate shocks

  (Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (MDA/2011/051)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 19 May 2011

• Ligasure blunt tip laparoscopic sealer/divider - potential risk of serious thermal burns

  (Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)

  • Alert type: Medical device alert
  • Medical specialism: General surgery and 3 others
  • Issued: 15 March 2011

• All types, makes and models of breast implants - potential increased risk of anaplastic large cell lymphoma (ALCL)

  (All) uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast - none reported in the UK. (MDA/2011/017)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery and 2 others
  • Issued: 16 February 2011

• Umbilical cord clamps - close the clamp by squeezing it at the grips until you hear a click

  (All) incorrect placement of the clamp on the umbilical cord has lead to improper seal and blood loss in a small number of cases, which can be fatal. (MDA/2010/094)

  • Alert type: Medical device alert
  • Medical specialism: Obstetrics and gynaecology and 1 others
  • Issued: 14 December 2010

• Recall of Avandia 4mg, 8mg, Avandamet 1mg/500mg, 2mg/500mg, 2mg/1000mg, 4mg/1000mg

  (GlaxoSmithKline (GSK)) Recall of all undispensed UK packs purchased through approved suppliers Alliance Healthcare and AAH Pharmaceuticals - class 3 action within 5 days. (EL(10)A/22)

  • Alert type: Drug alert
  • Medical specialism: Pharmacy
  • Issued: 21 October 2010

• Silicone gel filled breast implants - advice on clinical management of women with implants

  (Poly Implant Prothese (PIP)) advice for implanting surgeons to identify women with PIP implants and advise them that further testing will be carried out. (MDA/2010/078)

  • Alert type: Medical device alert
  • Medical specialism: General practice
  • Issued: 4 October 2010

• Intravenous (IV) extension sets with multiple ports - risk of backtracking

  (All brands) risk of back-tracking when an IV line has multiple access ports, which can lead to under-infusion or bolus delivery of IV drugs. (MDA/2010/073)

  • Alert type: Medical device alert
  • Medical specialism: Haematology and oncology
  • Issued: 20 September 2010

• LIFEPAK 20/20e defibrillator/monitor - component failures

  (Medtronic/Physio-Control) component failures affect AC (mains) and/or DC (battery) operating power, which may lead to the defibrillator not able to deliver therapy. (MDA/2010/070)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 9 September 2010

• Novabel® dermal filler - practitioners should stop use and return all unused products

  (Merz Pharmaceuticals GmbH) manufacturer has received reports of adverse reactions to the filler. (MDA/2010/064)

  • Alert type: Medical device alert
  • Medical specialism: General practice
  • Issued: 11 August 2010

• Anaesthetic vaporisers - failure to attach vaporisers to the anaesthetic machine causes gas leakage according to reports

  (All manufacturers) reports received: failure to correctly attach vaporisers to the anaesthetic machine backbar has led to anaesthetic gas leakage and patient awareness. (MDA/2010/052)

  • Alert type: Medical device alert
  • Medical specialism: General surgery and 1 others
  • Issued: 28 June 2010

• Fetal monitor/cardiotocograph (CTG) - adverse outcomes still reported

  (All) adverse outcomes are still reported when CTG traces appear normal - this replaces alert SN 2002(23) issued August 2002. (MDA/2010/054)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 28 June 2010

• Implantable vagus nerve stimulators (VNS) - follow manufacturer's latest field safety notices

  (Cyberonics VNS Therapy) device can have premature battery depletion (models 103 and 104), inaccurate battery life projection (models 103, 104 and 250), loss of therapy (all models) and painful, erratic or atypical stimulation (all models). (MDA/2010/050)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 15 June 2010

• Aquarius haemofiltration machines - follow instructions carefully

  (Edwards Lifesciences Ltd, supplied by Baxter Healthcare) reports that the wheels break if not used properly, which could cause the machine to fall over to cause injury and interrupt therapy. (MDA/2010/039)

  • Alert type: Medical device alert
  • Medical specialism: Renal medicine
  • Issued: 12 May 2010

• All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators - inadequate ventilation

  (All) harm of inadequate patient ventilation and oxygenation could have been avoided if an alternative means of ventilation had been used earlier. (MDA/2010/036)

  • Alert type: Medical device alert
  • Medical specialism: General surgery and 1 others
  • Issued: 6 May 2010

• All models and lot numbers of silicone gel filled breast implants - unapproved composition of silicone gel

  (Poly Implant Prothese (PIP)) French medical device regulatory authority (AFSSAPS) found the composition of silicone gel for most breast implants have been different to the one approved since 2001 (MDA/2010/025)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery
  • Issued: 31 March 2010

• Intracranial stent - don't use to treat intracranial aneurysms without embolisation coils

  (Balt Extrusion) potential for patient death if you use any SILK artery reconstruction device to treat intracranial aneurysms without embolisation coils. (MDA/2010/023)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 23 March 2010

• Hansen-type coloured dialysis fluid line connectors - incorrectly configured

  (All manufacturers) potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) which results in significantly less efficient dialysis. (MDA/2010/020)

  • Alert type: Medical device alert
  • Medical specialism: Renal medicine
  • Issued: 10 March 2010

• Teligen and Cognis defibrillators - risks for devices implanted subpectorally

  (Boston Scientific) specific models of defibrillators implanted subpectorally have a risk of loss of shock therapy, inappropriate shock therapy, loss of pacing therapy or loss of anti-tachycardia pacing. (MDA/2010/012)

  • Alert type: Medical device alert
  • Medical specialism: Critical care
  • Issued: 10 February 2010

• Intraocular lens (IOL) - hydrophilic acrylic - opacification

  (intraocular lens (IOL) - hydrophilic acrylic) opacification of intraocular lens (IOLs) may occur following intracameral use of alteplase. (MDA/2010/008)

  • Alert type: Medical device alert
  • Medical specialism: Ophthalmology
  • Issued: 21 January 2010

• Devices used for endometrial ablation - clinicians should confirm patients have no evidence of uterine perforation or false passage

  (All makes and models) MHRA receives reports of uterine wall injury, wall perforation or the creation of a false passage after use of endometrial ablation devices. (MDA/2010/006).

  • Alert type: Medical device alert
  • Medical specialism: Obstetrics and gynaecology
  • Issued: 18 January 2010

• All types of bed mattresses - contamination through damaged mattresses or covers

  (All types of bed mattresses) body or other fluids can pass through and contaminate inner core of damaged mattresses or covers and cause cross-infection if used. (MDA/2010/002)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 5 January 2010

• Medical devices in general and non-medical products - reminder of risks

  (General) Users should avoid (if possible), off-label use of medical devices, the modification of medical devices and the use of non CE-marked medical devices in clinical settings. (MDA/2010/001)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 4 others
  • Issued: 4 January 2010

• Ultrasound transducer - review advice by the Advisory Committee on Dangerous Pathogens (ACDP)

  (All manufacturers) Potential onward transmission of abnormal prion protein when ultrasound transducer probes with internal lumen during transrectal prostate biopsies on men at risk of vCJD. (MDA/2009/080)

  • Alert type: Medical device alert
  • Medical specialism: Infection prevention
  • Issued: 9 December 2009

• Aquarius haemofiltration machine - manufacturer has updated their actions for software problems

  (Edwards Lifesciences Ltd) the manufacturer has updated their corrective actions for software problems with haemofiltration machines. (MDA/2009/076)

  • Alert type: Medical device alert
  • Medical specialism: Renal medicine
  • Issued: 24 November 2009

• Kappa 600/700/900 series and Sigma 100/200/300 series pacemakers - potential unexpected failure

  (Medtronic Ltd) certain Kappa® and Sigma® series pacemakers may suddenly fail, which may cause bradycardia symptoms (fainting or light headedness) or serious injury/death in patients dependent on a pacemaker.(MDA/2009/038)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 10 June 2009

• Bioprosthetic heart valves - follow manufacturer's instructions to prepare implants before use

  (All makes and models) premature failure of bioprosthetic heart valves if they are not properly washed or rinsed before implantation. (MDA/2009/032)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 29 April 2009

• Goldmann applanation tonometer prism - use recommended disinfectants

  (Haag-Streit Ag) inappropriate disinfectants may cause damage the tonometer prism, which could result in corneal irritation. (MDA/2009/028)

  • Alert type: Medical device alert
  • Medical specialism: Ophthalmology
  • Issued: 21 April 2009

• Zenith abdominal aortic aneurysm (AAA) endovascular grafts and associated H&L-B One-Shot - serious injury or death of the patient during graft deployment

  (Cook Medical Incorporated) potential for serious injury or death of the patient due to the difficulty or inability to release the suprarenal stent during graft deployment. (MDA/2009/023).

  • Alert type: Medical device alert
  • Medical specialism: Cardiology
  • Issued: 2 April 2009

• UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems - identify affected devices and remove from service immediately

  (MECALL Srl) an X-ray tube head has fallen onto the table after the support cable and the backup ‘safety device’ failed at the same time. (MDA/2009/014)

  • Alert type: Medical device alert
  • Medical specialism: Radiology
  • Issued: 23 February 2009

• SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 implantable drug pumps - scan patients with these

  (Medtronic) Risk of delays in the resumption of drug infusion and in logging of motor stall events after MRI scans. (MDA/2008/087)

  • Alert type: Medical device alert
  • Medical specialism: General surgery
  • Issued: 18 December 2008

• Implantable cardioverter defibrillators (ICDs) - disable all high voltage shock therapies before you remove ICD

  (All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). (MDA/2008/068)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 2 others
  • Issued: 22 September 2008

• N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders neurostimulator programmers - error in programmer software

  (Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status. (MDA/2008/065)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 11 September 2008

• Lancing devices (used in pharmacy settings) - risk of transmission of blood borne infections

  (All brands) there is a risk of transmission of blood borne infections if a lancing device is used for testing between multiple patients contrary to the manufacturer's instructions for use. (MDA/2008/046)

  • Alert type: Medical device alert
  • Medical specialism: Haematology and oncology
  • Issued: 1 July 2008

• Implantable drug pumps for intrathecal therapy - risk of temporary or permanent neurological impairment

  (All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment. (MDA/2008/038)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 2 others
  • Issued: 9 June 2008

• Medical device alert: external temporary cardiac pacemaker (bedside model 4170 serial numbers 1 - 998) - return these to manufacturer and ensure rapid pace switch is off before you shut the device down

  (APC Medical Ltd) the manufacturer has found potential for rapid pacing while switching off this temporary pacemaker. (MDA/2007/095)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 2 others
  • Issued: 6 December 2007

• Medical device alert: Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - reports of lead conductor fracture

  (Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the UK including an investigation into a fatality. (MDA/2007/078)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 19 October 2007

• External pacemakers and temporary cardiac pacing leads - concerns that insecure systems still being used

  (All ) concerns that some insecure adaptor systems are being used to connect temporary pacing leads to external pacemakers. (MDA/2007/042)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 23 May 2007

• Flexible endoscopes - avoid placing device in storage and drying cabinets where ultraviolet light shines on them

  (Olympus) outer sheath and light guide tube of endoscopes may be damaged if directly exposed to ultraviolet (UV) light used in some endoscope storage and drying cabinets. (MDA/2007/034)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 1 others
  • Issued: 10 May 2007

• Patient hoists and slings - ensure you follow manufacturer's instructions for use and that you carry out risk assessments

  (All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities. (MDA/2007/031)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 1 others
  • Issued: 23 April 2007

• Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families - identify patients with these implants

  (Boston Scientific Ltd.) patients may experience extended charge times in the middle-of-life phase of the device, which could lead to a delay in shock delivery; also replacement and end of life indicators may display earlier than expected. (MDA/2007/023)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 2 others
  • Issued: 15 March 2007

• Lancing devices used in nursing homes and care homes - correction to list of disposable single-use lancing devices

  (All) MHRA continues to receive reports of hepatitis B outbreaks in nursing homes and care homes, which is linked with single-use lancing devices being used on multiple patients. (MDA/2006/066)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 6 December 2006

• Medical pacemakers (Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376) - perform a manual measured data reading in follow-ups

  (St Jude Medical UK Ltd) a programmer software anomaly can occur when these devices are used together, which can cause inaccurate display of battery voltage, battery longevity and elective replacement indicator (ERI) status. (MDA/2006/065)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 23 November 2006

• Hand pieces used with oral / maxillofacial surgery drills - ensure maintenance procedures are in place to prevent drill from overheating

  (General) significant increase in the number of reports from patients receiving oral burns from hand pieces used with overheated drills mostly due to lack of appropriate maintenance. (MDA/2006/055)

  • Alert type: Medical device alert
  • Medical specialism: Cosmetic surgery and 2 others
  • Issued: 21 September 2006

• Implantable pacemaker and implantable defibrillator families (INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR2, VENTAK PRIZM 2 VITALITY, VITALITY 2) - recall

  (Guidant) recall of subset of implantable pacemakers and defibrillators due to component failure that may lead to malfunction or premature depletion of battery. (MDA/2006/038)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 2 others
  • Issued: 13 July 2006

• MiniCap peritoneal dialysis disconnect cap with povidone-iodine - monitor thyroid function in patients with small fill volumes

  (Baxter Healthcare Ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (MDA/2006/022)

  • Alert type: Medical device alert
  • Medical specialism: Renal medicine
  • Issued: 22 March 2006

• All cochlear implants - update on immunisation recommendations

  (All) risk of pneumococcal meningitis in cochlear implant patients. (MDA/2006/019)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 3 others
  • Issued: 16 March 2006

• Sigma® implantable pacemakers - advise patients to contact their follow-up clinic immediately if they experience a return of symptoms

  (Medtronic) failure of interconnecting wires may cause loss of pacing output from atrial and or ventricular ports, premature depletion of battery, intermittent or total loss of telemetry, undersensing, high lead impedance values, loss of rate response, device reset to manufacturer's default settings. (MDA/2005/072)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 21 December 2005

• INSIGNIA and NEXUS implantable pacemakers - recall

  (Guidant) component failure. (MDA/2005/070)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 3 others
  • Issued: 19 December 2005

• INSIGNIA and NEXUS implantable pacemakers - consider replacement of elective device if there are one or more malfunctions

  (Guidant) device may have intermittent or permanent loss of pacing output without warning, intermittent permanent loss of telemetry, reversion to ventricular inhibited pacing (VVI), and/or reset warning message upon interrogation. (MDA/2005/067)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 4 others
  • Issued: 8 December 2005

• Implantable cardioverter defibrillators (ICDs) - ensure you have updated software for models 3510 and 3510+ ICD programmers

  (St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (MDA/2005/045)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 3 others
  • Issued: 25 July 2005

• Trilucent (soya bean oil filled) breast implants - update on actions from previous risks

  (Lipomatrix Inc) conclusions of research after device was recalled for risks of break down of filler and update of HN2000(05). (MDA/2004/047)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff and 2 others
  • Issued: 27 September 2004

• Implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx - identify affected patients

  (Medtronic) extended charge times and inability to deliver therapy for a subset of the above devices when battery voltages are close to elective replacement indicator (ERI). (MDA/2004/045)

  • Alert type: Medical device alert
  • Medical specialism: Critical care and 2 others
  • Issued: 9 September 2004

• Transilluminators used with neonates - ensure you follow the instructions and that the device can be used with neonates

  (All) use of an inappropriate light source for transillumination can result in burns. (MDA/2003/044)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 2 others
  • Issued: 2 December 2003

• Electrosurgical (diathermy) accessories - ensure procedures are in place to check all electrosurgical accessories regularly

  (All) malfunction and failure during use. (MDA/2003/037)

  • Alert type: Medical device alert
  • Medical specialism: General practice and 1 others
  • Issued: 27 October 2003

• SynchroMed® implantable drug pump - consider changing diamorphine for another medicine

  (Medtronic) diamorphine solution is incompatible with the implantable drug pump. (MDA/2003/035)

  • Alert type: Medical device alert
  • Medical specialism: Care home staff
  • Issued: 22 October 2003

• External pacemakers - sudden increase in pacing rate and change of mode

  (APC Medical Ltd) the pacing rate for models E4162, E4164, E4165 and E4166 may increase by 20 pulses per minute and change in pacing mode in some cases. (MDA/2003/008)

  • Alert type: Medical device alert
  • Medical specialism: Cardiology and 1 others
  • Issued: 27 March 2003

• Intra-oral dental X-ray units: IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510 – wall mount bracket may fail

  (Trophy (now owned by Carestream Health)) Risk of injury from falling unit after failure of the wall mount bracket. (MDA/2013/053)

  • Alert type: Medical device alert
  • Issued: 18 July 2013