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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
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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.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 03 September to 20 September 2018.
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List of field safety notices (FSNs) from medical device manufacturers from 28 August to 31 August
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Daiichi Sankyo UK Limited has informed us that there is an error on the blister foil of specific batches of Olmetec 20mg Film-Coated Tablets
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List of field safety notices (FSNs) from medical device manufacturers from 20 August to 24 August
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B. Braun Medical Ltd are recalling specific batches of Nutriflex Lipid Special without Electrolytes 2500ml as it's been identified that they may have an out of specification result in the glucose chamber at the end of th鈥�
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List of field safety notices (FSNs) from medical device manufacturers from 13 August to 17 August
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B. Braun Medical Ltd are recalling specific batches of Nutriflex Omega Special 2500ml as it's been identified that they may have an out of specification result in the glucose chamber at the end of their shelf life.
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List of field safety notices (FSNs) from medical device manufacturers from 6 August to 10 August
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List of field safety notices (FSNs) from medical device manufacturers from 30 July to 3 August 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 July 2018
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FDC International Ltd are recalling specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml due to the presence of a precipitate, which has been identified as Sodium C鈥�