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Summary List of field safety notices (FSNs) from medical device manufacturers from 6 February - 10 February 2017
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Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).
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Summary List of field safety notices (FSNs) from medical device manufacturers from 30 January - 3 February 2017
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(Bayer plc) Remaining stock of affected batches should be quarantined for uplift by Bayer - class 3 action within 5 days (EL (17)A/03)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 January 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 January 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 January 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 2 - 6 January 2017
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Following our latest review of medical device alerts, we have archived the ones listed below.
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Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26-30 December 2016
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Sanofi has informed us that there is an error in the Braille on some batches of Arava 10mg film-coated tablets (EL (17)A/01)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 December 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 - 16 December 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 December - 9 December 2016
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Medreich has provided handling instructions following several complaints that the child-resistant caps are difficult to open (EL(16)A/17)
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Updated advice from manufacturers on device management for systems known or suspected to be contaminated with Mycobacterium chimaera.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 28 November - 2 December 2016
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(Teva UK Limited) Precautionary batch recall of Evacal D3 1500mg/400iu Chewable Tablets after metal contamination was identified in a very small number of tablets
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Summary List of field safety notices (FSNs) from medical device manufacturers from 21 November - 25 November 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 14 November - 18 November 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 7 November -11 November 2016
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(Amdipharm UK Limited) Remaining stock of this batch should be quarantined and returned to the original supplier for credit - class 3 action within 5 days (EL (16)A/15)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 31 October - 4 November 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 October 2016
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A list of all medical device alerts that were archived in October 2016.
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Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
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If patients are contacted directly by a manufacturer or other organisation to try using a different insulin therapy system they should first discuss this with their diabetes specialist to avoid risk of hyperglycaemia, hypogl…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 October
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Action Within 48 Hours. Wholesaler and Pharmacy Level Recall. Teva UK Limited is recalling batches due to out of specification results for impurities obtained during routine stability testing.
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Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 October 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 3 - 7 October 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 - 30 September 2016
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Quadrant Pharmaceuticals Limited (repackaged by Pharmagen Limited) are asking pharmacists to check stocks of Adalat LA 30mg as there is a possibility that some packs of Parallel Imported LA 60mg may have been incorrectly rep…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 - 16 September 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 September 2016
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Sage Products Cooperatief UA: Precautionary recall of five batches due to low risk of microbiological contamination
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Ecolab are recalling batches of Klerpack BD Syringe Multi-Pack as the sterile packaging may contain small holes in the film of the pouch. (EL (16)A/13)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 - 9 September 2016
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Action within 48 hours: Novo Nordisk Ltd. is recalling seven batches of GlucaGen HypoKit due to a small number of needles being detached from the syringe.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August - 2 September 2016
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Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of he…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 August 2016
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Reports that rubber stopper may be pushed into vial during reconstitution, rendering the vial unusable. (EL (16)A/11)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 15 - 19 August 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 - 12 August 2016
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CSL Behring is recalling the listed batches due to reduced potency of the active ingredient.
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Bayer is recalling the listed batches due to reduced potency of the active ingredient
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Claris Lifesciences UK Ltd are asking pharmacists and wholesalers to check packs of Furosemide-Claris 20mg/2ml Injection (Marketing Authorisation number AUST R 148003) as they have been inadvertently distributed in the UK an…