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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 鈥� 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鈥�
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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 鈥� 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鈥�
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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鈥�
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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鈥�
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Action within 48 hours: Glaxo Wellcome UK Ltd is recalling 4 batches of Respontin Nebules due to out of specification results for impurities obtained during routine stability testing (EL (16)A/10)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 1 - 5 August 2016
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B Braun Medical Ltd is recalling the above batch as a precautionary measure because the Company has received isolated reports of patient reactions (fever, shivering) associated with administration of the batch.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 - 29 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18 - 22 July 2016
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A list of all medical device alerts that were archived in July 2016.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 - 15 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 4 - 8 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June - 1 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 20 - 24 June 2016
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Change to 2012 advice 鈥� current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.
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List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2016
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Caduceus Pharma Ltd., Pemetrexed 25mg/ml Concentrate for solution for Infusion: caution in use after particulates identified in a small number of vials (EL (16)A/09)
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Action within 48 hours: B&S Healthcare are recalling two batches of parallel imported Medikinet XL 20mg modified-release capsules that have been incorrectly repackaged in 30mg cartons. (EL (16)A/08)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 June 2016
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(Santen UK Ltd) Two batches of Ikervis 1 mg/ml eye drops, emulsion (30 single dose containers) (ciclosporin), are being recalled because micro particles of the active ingredient were found in stability test samples (EL(16)A/鈥�
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Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May - 3 June 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 May 2016
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(Special Products Ltd) A batch of Epistatus 10mg in 1ml Oromucosal Solution is being recalled due to the wrong size of neck adaptor in some bottles (EL (16)A/06)
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(Hospira UK Limited) Paclitaxel 6mg/ml concentrate for solution for infusion; 100mg in 16.7ml - risk of the exterior of vials contaminated with Methotrexate (EL (16)A/05)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 May 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 May 2016
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List of field safety notices (FSNs) from medical device manufacturers from 2 May to 6 May 2016