Sandy Health Centre

01767 682525

Health Visitors/District Nurses

01767 224100

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

Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection (MDA/2020/004)

Manufactured by Mavidon – products may be contaminated with the microorganism Burkholderia cepacia leading to an infection risk to patients. https://www.gov.uk/drug-device-alerts/skin-preparation-electrode-gel-recall-of-all-lots-of-lemonprep-pediaprep-wave-prep-and-cardio-prep-due-to-risk-of-contamination-and-transmission-of-infection-mda-2020-004?utm_source=28cdded1-9e16-4b15-828a-a9eff1a61887&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Field Safety Notice: 27 to 31 January

List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 2020. https://www.gov.uk/drug-device-alerts/field-safety-notice-27-to-31-january?utm_source=ba1defd5-15a9-410e-90bc-3fcbe75fd071&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate  

Class 2 Medicines recall: Medreich PLC, Ranitidine 150mg Tablets, PL 21880/0091, Ranitidine 300mg Tablets, PL 21880/0092 (EL (20)A/05)

Medreich Plc is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has … [continue] Class 2 Medicines recall: Medreich PLC, Ranitidine 150mg Tablets, PL 21880/0091, Ranitidine 300mg Tablets, PL 21880/0092 (EL (20)A/05)

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