-
Manufactured by NuVasive Inc. – risk of end cap separation after implantation.
-
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…
-
Manufactured by Cardinal Health – 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.
-
Manufactured by Terumo BCT – inadequately broken anticoagulant ‘frangible’ may lead to clotting and inadequate therapy during apheresis procedures.
-
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.
-
Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.
-
Manufactured by Baxter – Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown.
-
GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.
-
Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.
-
Manufactured by Becton Dickinson (BD) – 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.
-
Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
-
[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.
-
Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).
-
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.
-
Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
-
Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.
-
Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
-
Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
-
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.
-
Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
-
List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018
-
Manufactured by Acutronic Medical Systems AG – Ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
-
List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018
-
Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
-
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.
-
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.
-
IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
-
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)
-
FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
-
Caution in Use: Distribute to Pharmacy and Clinic Level.
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
-
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).
-
Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
-
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)
-
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…
-
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).
-
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.
-
Caution in Use: Distribute to Hospital Pharmacy and Ward Level.
-
Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.
-
Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
-
Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
-
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.
-
(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
-
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.
-
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.
-
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…
-
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.
-
Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
-
Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.