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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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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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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 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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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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This recall affects Mitomycin-C Kyowa 2 mg (PL 16508/0042), 10 mg (PL 16508/0043), 20 mg (PL 16508/0044), powder for solution for injection, and Mitomycin-C Kyowa 40 mg (PL 16508/0045), powder for intravesical solution.
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Manufactured by Philips 鈥� due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.
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Manufactured by Baxter 鈥� Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown.
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Manufactured by Ecolab/Microtek Medical Malta Ltd 鈥� bacterial contamination may cause an infection in patients.
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GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.
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Manufactured by Intersurgical 鈥� leaks or disconnection can result in insufficient oxygenation requiring medical intervention to avoid severe injury.
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Manufactured by Intersurgical, used in devices made by other companies: cracks in swivel elbow connectors may lead to prescribed ventilation not being delivered.
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Manufactured by CME (a BD company) 鈥� function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices.
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Manufactured by Defiteq International BV or GGT Holding BV 鈥� the safety and performance of these devices cannot be verified and their safe use can no longer be assured.
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Manufactured by Becton Dickinson (BD) 鈥� tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.
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Manufactured by Philips 鈥� devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.
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B. Braun Medical Ltd is Recalling batches as ongoing stability studies have identified that they may have an out of specification result in the glucose chamber at the end of shelf-life.
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Manufactured by Philips 鈥� this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
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[Archived] Manufactured by Vyaire 鈥� Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.
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[Archived]Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company 鈥� additional suitable battery identified for use in the T34 pump
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Manufactured by Roche Diabetes Care 鈥� Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).
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Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
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Manufactured by Medtronic Inc 鈥� a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N鈥憂itrosodiethylamine (NDEA).
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Manufactured by Eurotrol B.V 鈥� may give readings below the values assigned to the product, leading to incorrect measurement results.
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Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N鈥憂itrosodiethylamine (NDEA).
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Manufactured by GE Healthcare 鈥� Device may stop ventilation when in PSV Pro Mode and users may be unable to change gas and agent settings when using End-Tidal Control.
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N鈥憂itrosodiethylamine (NDEA).
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List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018
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Manufactured by Acutronic Medical Systems AG 鈥� Ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
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List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018
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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
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Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
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Cadiasun Pharma GmBH has informed us that there is an error on the patient information leaflet for Caspofungin 70mg powder for concentrate for solution for infusion.
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IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa庐, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
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FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
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Caution in Use: Distribute to Pharmacy and Clinic Level.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February 鈥� 02 March 2018
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Manufactured by AFP Medical 鈥� 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鈥�
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Manufactured by ICU Medical (formerly Hospira) 鈥� 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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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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Caution in Use: Distribute to Hospital Pharmacy and Ward Level.
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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.