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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and Company (BD)) – surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) is being withdrawn from hospitals and distribution centres.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
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List of field safety notices (FSNs) from medical device manufacturers from 22 October to 26 October
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List of field safety notices (FSNs) from medical device manufacturers from 15 October to 19 October
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List of field safety notices (FSNs) from medical device manufacturers from 8 October to 12 October
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List of field safety notices (FSNs) from medical device manufacturers from 1 October to 5 October
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Allergan Pharmaceuticals Ireland is recalling specific 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 24 September to 28 September
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List of field safety notices (FSNs) from medical device manufacturers from 17 September to 21 September
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Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect
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Cadiasun Pharma GmBH has informed us that there is an error on the patient information leaflet for Caspofungin 70mg powder for concentrate for solution for infusion.
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List of field safety notices (FSNs) from medical device manufacturers from 10 September to 14 September
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Thea Pharmaceuticals are recalling a specific batch of Mydriasert 0.28mg/5.4mg Ophthalmic Insert as it is labelled as being for the French market, rather than the UK market.