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List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 September 2019.
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List of field safety notices (FSNs) from medical device manufacturers from 27 to 30 August 2019.
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List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 August 2019.
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Manufactured by Equipmed and other trading names (listed in the ‘Manufacturer contacts’ section), distributed in the UK by Naturastudios. Do not use affected devices as they have been manufactured to unknown standards and th…
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List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 August 2019
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List of field safety notices (FSNs) from medical device manufacturers from 29 July to 2 August 2019
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Accord-UK Ltd is recalling the above batches due to the potential for small particles of Aripiprazole active material to be present which may affect the efficacy of the product. No relevant product complaints or adverse reac…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 July 2019.
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Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by Kosei Pharma, CST Pharma and Ordinant Medical Solutions from Italy and they …
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Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.
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Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.
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Chanelle Medical is recalling the above batch because a small number of packs have been found to contain tablets which are stuck together, with mould observed on some tablets. The mould has been identified as a Penicillium s…
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List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 July 2019
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 July 2019.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
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Martindale Pharma has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the EAN bar code for the following batches is incorrect.
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List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 July 2019
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List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 June 2019
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Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.
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Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled in B & S Healt…
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Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment.
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List of field safety notices (FSNs) from medical device manufacturers from 07 to 21 June 2019
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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