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Manufactured by Philips – 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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List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 April 2019
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Manufactured by Philips – 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 – 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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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 – 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‑nitrosodiethylamine (NDEA).
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Manufactured by Eurotrol B.V – 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‑nitrosodiethylamine (NDEA).
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Manufactured by GE Healthcare – 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‑nitrosodiethylamine (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 – 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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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®, 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 – 02 March 2018
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Manufactured by AFP Medical – 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…
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Manufactured by ICU Medical (formerly Hospira) – 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 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.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
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Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
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Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.
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Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.
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Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
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Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the…
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Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
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Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).
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Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
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Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038
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(All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines. Possible cause may be Mycobacterium-contaminated water…
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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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(St Jude Medical) These defibrillators can delay or reduce the therapy that can be delivered by the ICD.(MDA/2014/035)
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(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)
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(Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)
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(Hospira) Use an alternative pump, where available. (MDA/2013/078)