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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 March to the 30 March 2018
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Claris Lifesciences UK Limited are issuing a company-led drug alert for one batch of Mesna 100mg/ml solution for injection/infusion, 5 x 4ml due to stability issues (CLDA (18)A/01)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 March 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 March 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 March 2018
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AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure additional batches are also being recalled (EL(18)A/06)
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Following our latest review of medical device alerts, we have archived the ones listed below.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 February 2018
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Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (MDA/2018/008).
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Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)
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Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 February 2018
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Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 February 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 29 January to 2 February 2018
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Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous and Omniscan Solutions for injection 0.5 mmol/ml following a safety review of the gadolinium containing contra…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 January 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 January 2018
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 January 2018
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The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
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Manufactured by Boston Scientific: specific models only – risk of syncope or pre-syncope due to periods of pacing inhibition from oversensing of the minute ventilation sensor signal (MDA/2018/001)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 5 January 2018
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Winthrop Pharmaceuticals UK Limited (trading as Zentiva) is conducting a precautionary recall of a single batch of Molipaxin 100 mg capsules due to a potential issue with the metal detector during manufacture of the batch (E…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 to 29 December 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 December 2017
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Caution in Use: Distribute to Hospital Pharmacy and Ward Level.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 December 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 December 2017.
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Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.
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Takeda UK Ltd are issuing a company-led drug alert for one batch of Calcichew-D3 500mg/400 IU Caplets due to traces of a non-approved excipient (CLDA (17)A/05)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 November 2017.
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Pfizer is recalling the above batches as a precaution due to an out of specification result for microbiological testing during routine stability studies on a batch of the product which was not released to the market. (EL (17…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 November 2017.
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Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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Summary List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 November 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 30 October to 3 November 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 October 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 October 2017.
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Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 2017.
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Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 September 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 September 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 September 2017
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Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 1 September 2017