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Manufactured by Synthes GmbH 鈥� cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 29 June to 03 July 2020
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Manufactured by Abbott 鈥� cases of valvular insufficiency and early revision.
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BCM Specials Limited is recalling a specific batch of Mepacrine Hydroxychloride 100 mg tablets due to a number of foreign body particulates found in the containers of the API used to make it.
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Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.
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Manufactured by Philips 鈥� the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 22 June to 26 June 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 2020
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The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 08 to 12 June 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 01 to 05 May 2020
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Torbay Pharmaceuticals is recalling specific batches of Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) due to a potentially faulty and incorrectly engaged child-resistant container closure.
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This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)
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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 to 29 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 2020
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Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1鈥�
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As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies. An evaluation of the foil laminate pouch identified oxygen le鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 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 500 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 4 to 8 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 2020
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GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister鈥�
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TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the below batches is incorrect.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 6 to 9 April 2020
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All manufacturers 鈥� there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.
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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.