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All anaesthesia machines with ventilators - using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability.
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Pharmaswiss 膶eska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 300 microgram auto-injectors (also referred to as pens) from patients due to an error in one com鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 30 March to 3 April 2020
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Manufactured by NuVasive Specialized Orthopedics 鈥� supply of all MAGEC rods suspended to the UK market during a review by MHRA.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 2020
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Rosemont Pharmaceuticals Ltd has informed us of an error in the barcode and GTIN number of the label on the bottle of the below batches.
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Mylan UK Healthcare Ltd has informed us that the GTIN barcode applied on the below batches is incorrect.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 2020
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The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via WDA(H) 50340 HMS Wholesale Limited. This License has now been terminated鈥�
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Manufactured by NuVasive Inc. 鈥� risk of end cap separation after implantation.
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Gedeon Richter (UK) Ltd is recalling all unexpired stock of Esmya 5 mg tablets from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 March 2020
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Mylan UK Healthcare Ltd has informed us that a product complaint has been received relating to crystalline precipitate being observed during bottle use. Due to concerns with continuity of supply these batches are not being r鈥�
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Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2020
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Pharmaswiss 膶eska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) from patients due to an error in one com鈥�
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 February 2020
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AOP Orphan Pharmaceuticals AG is recalling all unexpired stock of a batch of Tetrabenazine 25 mg tablets (from pharmacies and wholesalers) as a precautionary measure due to out of specification results for the assay, obtaine鈥�
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Manufactured by Cardinal Health 鈥� calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.
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Manufactured by Olympus Medical Systems Corp 鈥� instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.
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G.L Pharma GmbH T/A Healthcare Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the specified batches is missing important safety relevant text changes.
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Manufactured by CME (a BD company) 鈥� updated advice to address 鈥榳ear and tear鈥� of the syringe pump motor block which may lead to under-infusion.
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Crescent Pharma Ltd has informed us of a discrepancy on the product packaging.
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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.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 February 2020
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Summary List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 February 2020
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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.
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Accord-UK Limited is recalling all unexpired stock of Gliclazide 40 mg Tablets (Northstar Livery) from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution, obtained durin鈥�
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Glaxo Wellcome UK Ltd T/A GSK has informed us of an issue related to error in the decommissioning of the K84X batch.
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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.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 February 2020
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Glenmark Pharmaceuticals is recalling specific batches as a precautionary measure.
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List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 2020.
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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 genotoxic 鈥�
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Wockhardt UK Ltd is recalling specific batches of Levothyroxine 100micrograms/5ml Oral Solution from pharmacies and wholesalers as a precautionary measure due to notification of the impurity liothyronine exceeding the specif鈥�
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Dr Reddy's Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the specific batches listed in this alert are missing the special warning and precautions identified from post-marketing exp鈥�
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List of field safety notices (FSNs) from medical device manufacturers from 20 January to 24 January 2020
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LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.
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List of field safety notices (FSNs) from medical device manufacturers from 13 January to 17 January 2020
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Caution in Use: Distribute to Pharmacy level. Advanz Pharma has informed us of a discrepancy on the product packaging. The discrepancy relates to 鈥渃apsules鈥� printed at the top right of the packs in error, instead of tablets
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List of field safety notices (FSNs) from medical device manufacturers from 06 to 10 January 2020.
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List of field safety notices (FSNs) from medical device manufacturers from 30 December 2019 to 3 January 2020.
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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 2019.
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Hospira UK Limited (Pfizer) is recalling specific batches as a precautionary measure.
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Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
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List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 December 2019.
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Manufactured by Flexicare Medical 鈥� loose bearings and retaining ring may enter patient鈥檚 airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.
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List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 December 2019.
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Accord Healthcare are recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
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Manufactured by Terumo BCT 鈥� inadequately broken anticoagulant 鈥榝rangible鈥� may lead to clotting and inadequate therapy during apheresis procedures.
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List of field safety notices (FSNs) from medical device manufacturers from 25 October to 29 November 2019.