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Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.
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List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 June 2019
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M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.
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List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 June 2019
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List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 May 2019
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Baxter Healthcare Limited has informed us that a quality defect has been identified with the above product where the front panel of a small number of infusion bags was found to be missing the red text.
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List of field safety notices (FSNs) from medical device manufacturers from 20 to 25 May 2019
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List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 May 2019
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 10 May 2019.
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Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle.
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Macopharma is recalling certain batches of intravenous infusion bags as a precaution. This is due to the detection of metal particles in two infusion bags.
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List of field safety notices (FSNs) from medical device manufacturers from 29 April to 3 May 2019.
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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 – 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…
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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 Informa…
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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).