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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 ‘P’. The Braille is missing from the carton and the packs contain the Patient Information …
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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 – 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…
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Manufactured by Philips – 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 – 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)) – 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 – 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 – 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 – 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‑nitrosodiethylamine (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 – may give readings below the values assigned to the product, leading to incorrect measurement results.
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Manufactured by ArjoHuntleigh AB – 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 – 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‑nitrosodiethylamine (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 – 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‑nitrosodiethylamine (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 – 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
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List of field safety notices (FSNs) from medical device manufacturers from 12 November to 16 November
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List of field safety notices (FSNs) from medical device manufacturers from 05 November to 09 November
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The above batch is being recalled because an out of specification result for sub visible particles was recorded at the 39 month time point
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List of field safety notices (FSNs) from medical device manufacturers from 29 October to 02 November