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Field Safety Notices – 2 to 6 March 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2020 https://www.gov.uk/drug-device-alerts/field-safety-notices-2-to-6-march-2020?utm_source=0166ef0b-a906-4346-b4f7-0cb3bbbfee7c&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Field Safety Notices – 24 to 28 February 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 February 2020 https://www.gov.uk/drug-device-alerts/field-safety-notices-24-to-28-february-2020?utm_source=90edc6de-c475-4456-9638-bcf1817f3884&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)

Manufactured by Olympus Medical Systems Corp – instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage. https://www.gov.uk/drug-device-alerts/various-olympus-duodenoscope-models-do-not-use-if-elevator-wires-are-frayed-or-damaged-as-these-may-cause-lacerations-to-patients-and-users?utm_source=2f678123-90a0-4502-af07-9f366af7f8ea&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDR/2020/007)

Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion. https://www.gov.uk/drug-device-alerts/all-t34-and-t34l-t60-ambulatory-syringe-pumps-check-pumps-before-each-use-due-to-risk-of-under-infusion-and-no-alarm-mdr-2020-007?utm_source=99dde68c-6a1d-4067-8280-044ecca0cc83&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10)

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect. https://www.gov.uk/drug-device-alerts/class-4-drug-alert-crescent-pharma-ltd-and-flamingo-pharma-uk-ltd-ibuprofen-400mg-tablets-el-20-a-10?utm_source=aff39c3b-5b36-48ff-8a55-feffba95d0ee&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Field Safety Notices – 17 to 21 February 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 February 2020 https://www.gov.uk/drug-device-alerts/field-safety-notices-17-to-21-february-2020?utm_source=cfe6db77-951e-41f6-8a83-40cfdad239e7&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10)

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect. https://www.gov.uk/drug-device-alerts/class-4-drug-alert-crescent-pharma-ltd-and-flamingo-pharma-uk-ltd-ibuprofen-400mg-tablets-el-20-a-10?utm_source=86bea001-3bba-4fed-8050-cded920eb303&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Field Safety Notices – 10 to 14 February 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 February 2020 https://www.gov.uk/drug-device-alerts/field-safety-notices-10-to-14-february-2020?utm_source=44f31e40-d618-4ed2-9949-bf1e44845201&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Field Safety Notices – 3 to 7 February 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 February 2020 https://www.gov.uk/drug-device-alerts/field-safety-notices-3-to-7-february-2020?utm_source=574378d3-6afa-48ee-9c98-6503cd917e7a&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Class 4 Medicines Defect Information: Atrolak XL Prolonged-release tablets, all strengths (quetiapine fumarate)

Accord Healthcare Ltd has informed us that the Patient Information Leaflet (PIL) for all strengths of Atrolak XL Prolonged-release tablets is missing the side effects identified from post-marketing experience. https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atrolak-xl-prolonged-release-tablets-all-strengths-quetiapine-fumarate?utm_source=efaf3e7c-9839-4fb3-bba8-0d1eab6d8f4b&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Class 3 FMD Medicines Recall, Beconase Aqueous Nasal Spray, (Beclometasone Dipropionate 50μg), PL 10949/0104, EL (20)A/07

Glaxo Wellcome UK Ltd T/A GSK has informed us of an issue related to error in the decommissioning of the K84X batch. https://www.gov.uk/drug-device-alerts/class-3-fmd-medicines-recall-beconase-aqueous-nasal-spray-beclometasone-dipropionate-50-g-pl-10949-0104-el-20-a-07?utm_source=30021dbd-64d4-4325-a81a-d380bf5b8060&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents (MDA/2020/006)

Manufactured by Cordis – instructions for use contain incorrect MRI compatibility information. https://www.gov.uk/drug-device-alerts/self-expanding-stents-s-m-a-r-t-and-precise-under-mri-various-risks-if-mri-is-operated-outside-the-required-conditions-for-these-stents-mda-2020-006?utm_source=2b29a714-2b89-421a-94b7-37f6d7daca9b&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection, PL 20075/0675, (EL (20)A/09)

Accord Healthcare Ltd has informed us of an issue related to the expiry date for the above batches, which has not been encoded in 2D data matrix. https://www.gov.uk/drug-device-alerts/class-4-fmd-medicines-defect-information-diamorphine-hydrochloride-bp-100-mg-lyophilisate-for-solution-for-injection-pl-20075-0675-el-20-a-09?utm_source=2843bd69-7c12-40f6-8454-645936690b1f&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

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