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Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 July 2017
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Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.
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Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 June 2017
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Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the…
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MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 June 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 June 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 June 2017
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Manufactured by Synthes GmbH - Recall of Radial Head Prosthesis System. Associated Radial Head Prosthesis system parts also need to be returned to DePuy Synthes but will be available for revision surgeries of the radial head…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 29 May to 2 June 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 May 2017.
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Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 15 May - 19 May 2017.
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FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.
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Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 May - 12 May 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 1 May - 5 May 2017
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Manufactured by LivaNova – increased risk of earlier than anticipated structural valve deterioration (SVD) particularly with the smaller sizes.
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Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 2017
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Biotest UK Ltd is recalling the listed batches due to low level contamination which occurred during manufacture
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18-21 April 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 April 2017
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
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Summary List of field safety notices (FSNs) from medical device manufacturers from 03-07 April 2017
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Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 - 31 March 2017
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Strides Pharma UK Ltd, trading as Co-pharma, is recalling specific batches of Diclo-SR 75 Tablets as a precautionary measure
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Summary List of field safety notices (FSNs) from medical device manufacturers from 20 - 24 March 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 - 17 March 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 March 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 February - 3 March 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 20 February - 24 February 2017
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Class 2 Medicines recall: UCB Pharma Limited are voluntarily recalling Viridal Duo Powder and Solvent for Injection (10mcg/ml and 40mcg/ml)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 February - 17 February 2017
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[Archived] Manufactured by CareFusion – Updates and replaces MDA/2016/023 as the manufacturer has now identified the potential for unintended bolus of medication when any syringe type is used in a pump that contain…
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Recall of Ergometrine Injections by hameln pharmaceuticals limited because the contents of some ampoules may not comply with the required specification.
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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)