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List of field safety notices (FSNs) from medical device manufacturers from 23 to 26 April 2019.
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Genesis Pharmaceuticals Ltd has informed us that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg. The printed text is correct on all packaging.
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Manufactured by Ethicon 鈥� use of affected devices may result in failure of staple line which could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding.
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Pfizer Limited has informed us that the text on the carton label for the above product has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules鈥�
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List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 April 2019
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List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 April 2019
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Martindale Pharmaceuticals has informed us of two issues with all unexpired batches of the above product, PL 00156/0109, legal status 鈥楶鈥�. The Braille is missing from the carton and the packs contain the Patient Information 鈥�
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List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 April 2019
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B. Braun Medical Ltd is Recalling batches as ongoing stability studies have identified that they may have an out of specification result in the glucose chamber at the end of shelf-life.
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Ranbaxy (UK) Ltd a Sun Pharmaceutical Company, has informed us that some packs from a batch of Zoledronic acid 5mg solution for infusion contain a Patient Information Leaflet for Temozolomide 180mg Capsules.
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List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 March.
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Manufactured by Fresenius Medical 鈥� inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.
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List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 March 2019.
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Further to previous recalls of Valsartan and Irbesartan containing products, which were potentially contaminated with N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), we have become aware of products containing鈥�
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Manufactured by Philips 鈥� this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 March 2019
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Allergan Pharmaceuticals Ireland is further recalling batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.
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List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 March 2019
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[Archived] Manufactured by Vyaire 鈥� Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.
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List of field safety notices (FSNs) from medical device manufacturers from 25 February 2019 - 1 March 2019
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Manufactured by C.R. Bard (Becton, Dickinson and Company (BD)) 鈥� surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) is being withdrawn from hospitals and distribution centres.
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[Archived]Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company 鈥� additional suitable battery identified for use in the T34 pump
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Accord Healthcare Limited has informed us that there is an error on the portion of the Patient
Information Leaflet (PIL) for the Paracetamol Infusion which is intended for Healthcare Professionals.
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List of field safety notices (FSNs) from medical device manufacturers from 18-22 February 2019
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Manufactured by Roche Diabetes Care 鈥� Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 February 2019
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Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
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Manufactured by Medtronic Inc 鈥� a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N鈥憂itrosodiethylamine (NDEA).
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List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 February 2019
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019
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List of field safety notices (FSNs) from medical device manufacturers from 28 January to 1 February 2019
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Accord Healthcare Limited has informed us that that a change to the Patient Information Leaflet (PIL) for
this product has not been implemented by the required timeline.
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Manufactured by Eurotrol B.V 鈥� may give readings below the values assigned to the product, leading to incorrect measurement results.
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Manufactured by ArjoHuntleigh AB 鈥� spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.
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Manufactured by Abbott 鈥� some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 January 2019
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Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N鈥憂itrosodiethylamine (NDEA).
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 January 2019
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Manufactured by GE Healthcare 鈥� Device may stop ventilation when in PSV Pro Mode and users may be unable to change gas and agent settings when using End-Tidal Control.
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List of field safety notices (FSNs) from medical device manufacturers from 31 December 2018 to 4 January 2019
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N鈥憂itrosodiethylamine (NDEA).
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List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018
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Manufactured by Acutronic Medical Systems AG 鈥� Ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
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List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 03 to 07 December 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 November 2018
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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
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Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
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List of field safety notices (FSNs) from medical device manufacturers from 19 November to 23 November