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(All) malfunction and failure during use. (MDA/2003/037)
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Manufactured by Acutronic Medical Systems AG – 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 Field Safety Notices: 8 to 12 November 2021
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Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the below batches of products.
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(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerede Adrenaline Autoinjectors after identifying an error than can cause some pens to fail to activate.
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Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm i…
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hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
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Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.
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Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.
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This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices. It is aimed at all parts of the hea…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 October
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 October 2016
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Rosemont Pharmaceuticals Limited has informed the MHRA that the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) of a specific batch is too wide to fit the neck of the medicine bottle.
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Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical error in the leaflet.
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Atnahs Pharma UK has informed the MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information.
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Pharmaswiss Česka 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…
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The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.
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The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.
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Manufactured by Intersurgical – leaks or disconnection can result in insufficient oxygenation requiring medical intervention to avoid severe injury.
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(Medtronic) diamorphine solution is incompatible with the implantable drug pump. (MDA/2003/035)
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Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.
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Regular safety information for healthcare professionals
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 January 2017
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Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June - 1 July 2016
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Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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(Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status. (MDA/2008/065)
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Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.
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Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
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(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)
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(All makes and models) premature failure of bioprosthetic heart valves if they are not properly washed or rinsed before implantation. (MDA/2009/032)
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(All makes and models) MHRA receives reports of uterine wall injury, wall perforation or the creation of a false passage after use of endometrial ablation devices. (MDA/2010/006).
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(Carestream Health) Risk of injury if joint between scissor arm and bracket fails. (MDA/2014/005)
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Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.
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(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)
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(All products) Could fail during use with a risk of injury to patient and user. (MDA/2014/004)
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(All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities. (MDA/2007/031)
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Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a ware…
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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.
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(Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (MDA/2011/051)
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(All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model. (MDA/2013/028)
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(St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (MDA/2005/045)
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(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)
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(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)
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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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Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer for vigabatrin.