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Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision
Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
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Field Safety Notice - 16 to 20 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 April 2018.
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Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)
Caution in Use: Distribute to Pharmacy and Clinic Level.
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Field Safety Notice - 02 to 06 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 April 2018
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Field Safety Notice - 26 to 30 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 March to the 30 March 2018
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All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment
Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)
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Mesna 100mg/ml solution for injection/infusion, 5 x 4ml - company led recall
Claris Lifesciences UK Limited are issuing a company-led drug alert for one batch of Mesna 100mg/ml solution for injection/infusion, 5 x 4ml due to stability issues (CLDA (18)A/01)
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Field Safety Notice - 19 to 23 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 March 2018
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Field Safety Notice - 12 to 16 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 March 2018
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Field Safety Notice - 5 to 9 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 March 2018
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Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)
AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit.
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Medical device alerts archived in March 2018
Following our latest review of medical device alerts, we have archived the ones listed below.
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Field Safety Notice - 26 February – 02 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
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Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure
Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)
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Field Safety Notice - 19 to 23 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 February 2018
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Aquilon series of nebulisers – CE mark withdrawn and supply ceased
Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (MDA/2018/008).
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Class 4 Medicines Defect Information: Bleo-Kyowa, powder for solution for injection, 15,000 IU
Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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Class 2 Medicines Recall: Seretide Accuhaler 50 microgram/250 microgram/dose inhalation powder, pre-dispensed
Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)
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Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate)
Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL (18) A/03)
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Field Safety Notice - 12 to 16 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 February 2018
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Zimmer Biomet, specific hip and trauma instruments: risk of infection
Manufactured by Zimmer GmbH – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions (MDA/2018/007).
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Plum 360 infusion pumps – user actions required to prevent risk of interrupted infusion or delay to treatment
Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
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Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents
Roche Tissue Diagnostics (Ventana Medical Systems) – Leaking and sticking reagent dispensers may cause weak staining on tissue samples, which may lead to false negatives and misdiagnosis.
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Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors
Manufactured by Teleflex – risk of misdiagnosis and delivery of inappropriate treatment as sensors may give an inaccurate temperature reading.
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Field Safety Notice - 5 to 9 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 February 2018
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Field Safety Notice - 29 January - 2 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 January to 2 February 2018
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Class 2 Medicines Recall: Magnevist and Omniscan Solutions for injection EL (18) A/02
Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous and Omniscan Solutions for injection 0.5 mmol/ml following a safety review of the gadolinium containing contrast media by the European Medicines Agency (EMA).
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Field Safety Notice - 22 to 26 January 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 January 2018
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Field Safety Notice - 15 to 19 January 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 January 2018
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In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products – precautionary measure
Manufactured by CooperSurgical: specific batches of products were manufactured with increased histamine levels in the gentamicin sulphate.
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Field Safety Notice - 8 to 12 January 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 January 2018
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All Philips HeartStart MRx monitors/defibrillators – significant delay in the supply of batteries
The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
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Pacemakers and CRT-P - oversensing of minute ventilation sensor signal leading to risk of syncope and pre-syncope
Manufactured by Boston Scientific: specific models only – risk of syncope or pre-syncope due to periods of pacing inhibition from oversensing of the minute ventilation sensor signal (MDA/2018/001)
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Field Safety Notice - 2 to 5 January 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 5 January 2018
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Class 2 Medicines Recall: Molipaxin 100 mg capsules (one batch)
Winthrop Pharmaceuticals UK Limited (trading as Zentiva) is conducting a precautionary recall of a single batch of Molipaxin 100 mg capsules due to a potential issue with the metal detector during manufacture of the batch (EL(18) A/01).
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Field Safety Notice - 27 to 29 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 to 29 December 2017
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Field Safety Notice - 18 to 22 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 December 2017
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AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop
Risk of injury to the patient if the treadmill suddenly goes to top speed.
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Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion
BD Alaris/Asena syringe pumps (specific product codes) – internal malfunction may cause PL3 alarm to sound and the infusion to stop (MDA/2017/036).
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Nasogastric (NG) feeding tubes – recall due to risk of neonatal or paediatric patient choking on ENFIT connector cap
Manufactured by Maxter Catheters – patients could accidentally pull off the connector cap and choke on it. (MDA/2017/035)
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Class 4 Medicines Defect Information: Co-Amoxiclav 1000mg/200mg Powder for Solution (EL (17) A-14)
Caution in Use: Distribute to Hospital Pharmacy and Ward Level.
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Field Safety Notice - 11 to 15 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 December 2017.
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Field Safety Notice - 4 to 8 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 December 2017.
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Class 4 Medicines Defect Information: BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes
Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
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Field Safety Notice - 27 November to 1 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.
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Calcichew-D3 500mg/400 IU Caplets - Pharmacy level recall
Takeda UK Ltd are issuing a company-led drug alert for one batch of Calcichew-D3 500mg/400 IU Caplets due to traces of a non-approved excipient (CLDA (17)A/05)
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Field Safety Notice - 20 to 24 November 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 November 2017.
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Class 2 Medicines Recall: Lipitor (Atorvastatin) 80mg film-coated tablets / Atorvastatin 80mg film-coated tablets, Almus livery
Pfizer is recalling the above batches as a precaution due to an out of specification result for microbiological testing during routine stability studies on a batch of the product which was not released to the market. (EL (17) A/12)
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ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc – potential for false resistance results if stored at the wrong temperature
Manufactured by Oxoid Ltd (ThermoFisher Scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°C and 8°C: only specific lots are affected (MDA/2017/034)
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Field Safety Notice - 23 to 27 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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