GOV.UK
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Field Safety Notice - 19 to 23 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 June 2017
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BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment
Manufactured by Intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
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Field Safety Notice - 12 to 16 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 June 2017
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Field Safety Notice - 5 to 9 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 June 2017
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DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem
Manufactured by Synthes GmbH - Recall of Radial Head Prosthesis System.
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Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff
Manufactured by Intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
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Field Safety Notice - 29 may to 2 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 May to 2 June 2017
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Field Safety Notices - 22 - 26 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 May 2017.
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All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring
Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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Field Safety Notice - 15 to 19 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 15 May - 19 May 2017.
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Class 2 Medicines Recall: Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops
FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.
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All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy
Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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V60 ventilator – potential for unexpected shutdown
Manufactured by Philips Respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown
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Field Safety Notice - 8 to 12 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 May - 12 May 2017.
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Field Safety Notice - 1 May to 5 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 1 May - 5 May 2017
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Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration
Manufactured by LivaNova – increased risk of earlier than anticipated structural valve deterioration (SVD) particularly with the smaller sizes.
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All Accu-Chek® Insight insulin pumps – updated information for battery management
Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
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Field Safety Notice - 24 April to 28 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 2017
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Recall of Human Albumin Biotest CLDA (17)A/02
Biotest UK Ltd is recalling the listed batches due to low level contamination which occurred during manufacture
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Field Safety Notice - 18 April to 21 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18-21 April 2017
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BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy
Manufactured by Becton Dickinson (BD) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.
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LMA mucosal atomization devices - topical anaesthesia may not be delivered in a fully atomised spray
Manufactured by Teleflex – Poor atomisation of the spray could result in inadequate topical anaesthesia delivery, which may lead to discomfort or difficulties delivering anaesthesia
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LMA® MAD Nasal™ intranasal mucosal atomization device – might not deliver a fully atomised plume of medication
Manufactured by Teleflex – failure of the device to deliver an atomised plume may impair the effectiveness of the medication, potentially resulting in serious injury or a life-threatening situation
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Field Safety Notice - 10 April to 14 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 April 2017
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
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Field Safety Notice - 03 April to 07 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 03-07 April 2017
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Comprehensive Reverse Titanium Shoulder Tray (specific lots) - risk of device fracture
Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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Field Safety Notice - 27 March to 31 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 - 31 March 2017
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Class 2 Medicines Recall: Diclo-SR 75 Tablets (Diclofenac Sodium)
Strides Pharma UK Ltd, trading as Co-pharma, is recalling specific batches of Diclo-SR 75 Tablets as a precautionary measure
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Field Safety Notices - 20 March - 24 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 - 24 March 2017
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Field Safety Notices - 13 March - 17 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 13 - 17 March 2017
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Field Safety Notices - 6 March - 10 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 March 2017
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CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP – damaged lithium ion batteries may give off smoke, a bad smell or produce sparks
Manufactured by Maquet – until storage cases are available, avoid carrying spare batteries when transporting the IABP to reduce the risk of dropping and damaging them.
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Field Safety Notices - 27 February - 3 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 February - 3 March 2017
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Field Safety Notices - 20 February - 24 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 February - 24 February 2017
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Precautionary recall of Viridal Duo Powder and Solvent for Injection (EL (17)A/04)
Class 2 Medicines recall: UCB Pharma Limited are voluntarily recalling Viridal Duo Powder and Solvent for Injection (10mcg/ml and 40mcg/ml)
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Field Safety Notices - 13 February - 17 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 13 February - 17 February 2017
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Alaris® syringe pumps (GH, CC, TIVA & PK models) – risk of uncontrolled bolus of medicine.
Manufactured by CareFusion – Updates and replaces MDA/2016/023 as the manufacturer has now identified the potential for unintended bolus of medication when any syringe type is used in a pump that contains a broken spring in the plunger assembly.
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Reflection® dead blow mallet (all batches) – risk of exposure to lead particles
Manufactured by Smith & Nephew – cracking of the welds on the head of the mallet can result in lead particles escaping and entering the surgical wound, potentially resulting in effects associated with lead exposure.
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Precautionary recall of Ergometrine Injections (CLDA (17)A/01)
Recall of Ergometrine Injections by hameln pharmaceuticals limited because the contents of some ampoules may not comply with the required specification.
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Field Safety Notices - 6 February - 10 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 February - 10 February 2017
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Oxylog 3000 and Oxylog 3000 plus ventilator – risk of failure
Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).
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Field Safety Notices - 30 January - 3 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 January - 3 February 2017
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Alka-Seltzer Original & Alka-Seltzer XS - recall of some batches due to an issue with the blister foil
(Bayer plc) Remaining stock of affected batches should be quarantined for uplift by Bayer - class 3 action within 5 days (EL (17)A/03)
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Field Safety Notices - 23 January - 27 January 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 January 2017
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Field Safety Notices - 16 January - 20 January 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 January 2017
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Field Safety Notices - 9 January - 13 January 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 January 2017
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Field Safety Notices - 2 January - 6 January 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 2 - 6 January 2017
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Medical device alerts archived in January 2017
Following our latest review of medical device alerts, we have archived the ones listed below.
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Class 4 Caution in Use : Mirena 20 micrograms / 24 hours intrauterine delivery system
Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle
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