tag:www.gov.uk,2005:/drug-device-alerts Alerts, recalls and safety information: medicines and medical devices about Care home staff 2025-04-02T14:01:02+01:00 HM Government tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-14 2025-04-02T14:01:02+01:00 Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14 Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being sta… tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-argenx-bv-vyvgart-1000-mg-solution-for-injection-el-24-a-slash-63 2024-12-19T11:06:52+00:00 Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63 Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted. tag:www.gov.uk,2005:/drug-device-alerts/philips-respironics-bipap-a-series-ventilators-alarm-malfunction-and-risk-of-therapy-interruptions-in-ventilators-not-intended-for-life-support-dsi-slash-2024-slash-006 2024-10-02T12:03:28+01:00 Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006 Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential los… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-pfizer-limited-oxbryta-500mg-tablets-voxelotor-el-24-a-slash-44 2024-09-30T13:15:15+01:00 Class 2 Medicines Recall: Pfizer Limited, Oxbryta 500mg Tablets (voxelotor), EL(24)A/44 Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-glaxo-wellcome-uk-limited-trading-as-glaxosmithkline-uk-flolan-1-dot-5-mg-powder-and-solvent-for-solution-for-infusion-el-24-a-slash-30 2024-07-22T15:01:01+01:00 Class 2 Medicines Recall: Glaxo Wellcome UK Limited (trading as GlaxoSmithKline UK), Flolan 1.5 mg Powder and Solvent for Solution for Infusion, EL(24)A/30 Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-desitin-pharma-uk-ltd-lamotrigine-desitin-10mg-slash-ml-oral-suspension-el-24-a-slash-20 2024-06-06T13:59:27+01:00 Class 2 Medicines Recall: Desitin Pharma UK Ltd, Lamotrigine Desitin 10mg/ml Oral Suspension, EL(24)A/20 Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testin… tag:www.gov.uk,2005:/drug-device-alerts/0-dot-9-percent-sodium-chloride-solutions-for-irrigation-inhalation-and-eyewash-recall-from-manufacturer-legency-remedies-dsi-slash-2024-slash-004 2024-04-04T14:02:30+01:00 0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash: recall from manufacturer Legency Remedies, DSI/2024/004 Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination. tag:www.gov.uk,2005:/drug-device-alerts/counterfeits-and-unbranded-copies-of-lifevac-anti-choking-devices-may-fail-to-work-correctly-or-worsen-choking-incidents-if-used-dsi-slash-2024-slash-003 2024-03-25T11:00:08+00:00 Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used, DSI/2024/003 Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK o… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-novartis-pharmaceuticals-uk-limited-adakveo-10-mg-slash-ml-concentrate-for-solution-for-infusion-el-24-a-slash-06 2024-02-21T10:56:35+00:00 Class 2 Medicines Recall: Novartis Pharmaceuticals UK Limited, Adakveo 10 mg/ml concentrate for solution for infusion, EL(24)A/06 Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-medical-beds-trolleys-bed-rails-bed-grab-handles-and-lateral-turning-devices-risk-of-death-from-entrapment-or-falls-natpsa-slash-2023-slash-010-slash-mhra 2023-08-30T14:30:55+01:00 National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA) The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-b-braun-medical-ltd-various-products-el-23-a-slash-27 2023-07-31T12:55:32+01:00 Class 2 Medicines Recall: B. Braun Medical Ltd, Various Products, EL(23)A/27 B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-buccolam-10mg-oromucosal-solution-el-23-a-slash-18 2023-05-22T14:00:14+01:00 Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution, EL (23)A/18 Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-emerade-500-micrograms-and-emerade-300-micrograms-auto-injectors-due-to-the-potential-for-device-failure-natpsa-slash-2023-slash-004-slash-mhra 2023-05-09T12:30:14+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure, NatPSA/2023/004/MHRA Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-pholcodine-containing-products-el-23-a-slash-09 2023-03-14T11:01:17+00:00 Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09 Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution. tag:www.gov.uk,2005:/drug-device-alerts/bd-bodyguard-microsets-and-residual-ethylene-oxide-devices-may-continue-to-be-used-to-treat-paediatric-patients-5kg-and-above-dsi-slash-2023-slash-004 2023-02-20T15:55:47+00:00 BD BodyGuard MicroSets and residual ethylene oxide: devices may continue to be used to treat paediatric patients 5kg and above, DSI/2023/004 As a precautionary measure, following an MHRA assessment of currently available data on EO levels, alternative devices to the BD BodyGuard Microsets should be sought in users of 5kg bodyweight and below. tag:www.gov.uk,2005:/drug-device-alerts/nexgen-knee-replacement-affected-patients-should-be-offered-additional-follow-up 2023-02-15T12:43:56+00:00 NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003 The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Fem… tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-21-to-25-november-2022 2022-11-28T15:34:54+00:00 Field Safety Notices: 21 to 25 November 2022 List of Field Safety Notices (FSNs) from 21 to 25 November 2022 tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-4-medicines-defect-information-prenoxad-1mg-slash-ml-solution-for-injection-macarthys-laboratories-aurum-pharmaceuticals-ltd-slash-ethypharm-group-due-to-potential-missing-needles-in-sealed-kits 2022-11-10T13:00:37+00:00 National Patient Safety Alert: Class 4 Medicines Defect Information: Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-targocid-200mg-powder-for-solution-for-injection-slash-infusion-or-oral-solution-aventis-pharma-limited-t-slash-a-sanofi-due-to-the-presence-of-bacteria 2022-10-21T11:00:35+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-hikma-pharmaceuticals-usa-inc-lorazepam-2mg-slash-ml-injection-lorazepam-4mg-slash-ml-injection-unlicensed-medicines 2022-08-30T11:00:10+01:00 Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines), EL(22)A/37 Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-mexiletine-hydrochloride-50mg-100mg-and-200-mg-hard-capsules-clinigen-healthcare-ltd-due-to-a-potential-for-underdosing-and-slash-or-overdosing-natpsa-s 2022-08-04T14:28:26+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRA Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-fresenius-kabi-limited-sodium-bicarbonate-1-dot-26-percent-solution-for-infusion-el-22-a-slash-20 2022-04-28T13:00:27+01:00 Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20 Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-34 2021-12-01T16:55:42+00:00 Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34 Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-rosemont-pharmaceuticals-limited-metformin-hydrochloride-500mg-slash-5ml-oral-solution-pl-00427-slash-0139-el-21-a-slash-20 2021-08-25T13:00:19+01:00 Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL (21)A/20 Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-19 2021-08-09T11:00:31+01:00 Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL (21)A/19 Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-kyowa-kirin-limited-xomolix-2-dot-5-mg-slash-ml-solution-for-injection-el-21-a-slash-15 2021-07-01T11:00:57+01:00 Class 2 Medicines Recall: Kyowa Kirin Limited, Xomolix 2.5 mg/ml solution for injection, EL (21)A/15 Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-philips-ventilator-cpap-and-bipap-devices-potential-for-patient-harm-due-to-inhalation-of-particles-and-volatile-organic-compounds-natpsa-slash-2021-slash-005-slash-mhra 2021-06-23T15:51:45+01:00 National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds (NatPSA/2021/005/MHRA) Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-brown-and-burk-uk-ltd-teva-uk-ltd-irbesartan-containing-and-losartan-containing-products-el-21-a-slash-14 2021-06-17T10:00:43+01:00 Class 2 Medicines Recall: Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products, EL (21)A/14 Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-co-codamol-30-slash-500-effervescent-tablets-batch-1k10121-zentiva-pharma-uk-ltd-due-to-precautionary-risk-of-causing-overdose-natpsa-slash-2021-slash-0 2021-06-16T11:00:08+01:00 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd, due to precautionary risk of causing overdose, NatPSA/2021/004/MHRA Zentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for … tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-supply-disruption-of-sterile-infusion-sets-and-connectors-manufactured-by-becton-dickinson-bd-natpsa-slash-2021-slash-001-slash-mhra 2021-03-11T16:33:47+00:00 National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA) BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-eaststone-limited-midabuc-midazolam-as-hcl-10mg-slash-ml-oromucosal-solution-el-21-a-slash-04 2021-02-16T10:00:09+00:00 Class 2 Medicines Recall: Eaststone Limited, MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution, EL (21)A/04 Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-ambisome-liposomal-50-mg-powder-for-dispersion-for-infusion-pl-16807-slash-0001-el-21-a-slash-03 2021-02-11T12:30:38+00:00 Class 4 Medicines Defect Information, AmBisome Liposomal 50 mg Powder for dispersion for infusion, (PL 16807/0001), EL (21)A/03 Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-… tag:www.gov.uk,2005:/drug-device-alerts/company-led-drug-alert-optiray-300mg-i-ml-solution-for-injection-or-infusion-pl-12308-0028-and-optiray-350mg-i-ml-solution-for-injection-or-infusion-pl-12308-0032 2020-10-22T15:00:29+01:00 Company led drug alert - Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032) Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of… tag:www.gov.uk,2005:/drug-device-alerts/results-from-laboratory-based-tests-for-covid-19-antibodies-using-capillary-blood-sample-collection-kits-may-not-be-reliable-mda-2020-015 2020-06-08T10:01:28+01:00 Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015) 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) tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-emerade-500-micrograms-solution-for-injection-in-pre-filled-syringe-pl-33616-0015-el-20-a-23 2020-05-18T11:01:00+01:00 Class 2 Medicines Recall: Emerade 500 micrograms solution for injection in pre-filled syringe, PL 33616/0015 (EL(20)A/23 Pharmaswiss Česka 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… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-emerade-300-micrograms-solution-for-injection-in-pre-filled-syringe-pl-33616-0014-el-20-a-20 2020-04-07T11:00:05+01:00 Class 2 Medicines Recall: Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20) Pharmaswiss Česka 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… tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-emerade-150-micrograms-solution-for-injection-in-pre-filled-syringe-pl-33616-0013-el-20-a-14 2020-03-04T14:00:10+00:00 Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe, PL 33616/0013 (EL(20)A/14) 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… tag:www.gov.uk,2005:/drug-device-alerts/tympanic-thermometers-revision-of-the-calibration-frequency-of-cardinal-health-genius-2-and-genius-3-models 2020-02-27T14:00:37+00:00 Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models 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. tag:www.gov.uk,2005:/drug-device-alerts/all-t34-and-t34l-t60-ambulatory-syringe-pumps-check-pumps-before-each-use-due-to-risk-of-under-infusion-and-no-alarm-mdr-2020-007 2020-02-25T12:28:35+00:00 All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDA/2020/007) 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. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-zantac-injection-50mg-2ml-zantac-syrup-150mg-10ml-zantac-tablets-150mg-zantac-tablets-300mg-el-19-a-24 2019-10-08T15:32:28+01:00 Class 2 Medicines recall: Zantac Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24) GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies. tag:www.gov.uk,2005:/drug-device-alerts/all-models-of-t34-ambulatory-syringe-pumps-updated-cleaning-advice-and-maintenance-requirements-due-to-the-risk-of-fluid-ingress-mda-2019-030 2019-09-18T14:05:23+01:00 All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030) Manufactured by CME (a BD company) – function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices. tag:www.gov.uk,2005:/drug-device-alerts/automated-external-defibrillators-all-telefunken-hr1-fa1-no-valid-ce-certificate-mda-2019-027 2019-07-25T14:05:29+01:00 Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate (MDA/2019/027) 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. tag:www.gov.uk,2005:/drug-device-alerts/professional-use-capillary-blood-specimen-collection-bd-microtainer-tubes-risk-of-blood-leakage-and-or-incorrect-test-results-due-to-defective-tubes 2019-07-24T14:10:33+01:00 Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes 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. tag:www.gov.uk,2005:/drug-device-alerts/all-t34-ambulatory-syringe-pumps-update-concerning-battery-information-mda-2018-035 2019-03-04T12:31:30+00:00 All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035) [Archived]Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump tag:www.gov.uk,2005:/drug-device-alerts/accu-chek-insight-insulin-pumps-some-need-to-be-fitted-with-key-frames-to-reduce-the-risk-of-accidentally-unlocking-keys-or-pressing-the-bolus-buttons 2019-02-19T12:00:30+00:00 Accu-Chek® Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009). tag:www.gov.uk,2005:/drug-device-alerts/class-4-defect-information-atropine-sulfate-3mg-10ml-solution-for-injection-in-pre-filled-syringe-mdr-18-01-19 2019-02-18T11:07:10+00:00 Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19) 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. tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-actavis-group-ptc-ehf-irbesartan-300mg-film-coated-tablets-pl-30306-0108-and-irbesartan-hydrochlorothiazide-300-25mg-film-coated-tablets-pl-30306-0267-mdr-94-06-18 2019-02-13T10:59:40+00:00 Class 2 Medicines recall: Actavis Group PTC EHF - Irbesartan 300mg Film-coated tablets, PL 30306/0108 and Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267 (MDR 94-06/18) Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA). tag:www.gov.uk,2005:/drug-device-alerts/recall-of-certain-batches-of-eurotrol-haemoglobin-controls-due-to-microbial-contamination-mda-2019-005 2019-01-30T15:31:22+00:00 Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005) Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results. tag:www.gov.uk,2005:/drug-device-alerts/arjo-minstrel-passive-floor-lift-portable-hoist-risk-of-spreader-bar-detachment-from-lifts-without-a-scale-mda-2019-004 2019-01-30T11:00:14+00:00 Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts without a scale (MDA/2019/004) Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient. tag:www.gov.uk,2005:/drug-device-alerts/freestyle-libre-flash-glucose-sensor-use-of-barrier-methods-to-reduce-skin-reactions-to-the-sensor-adhesive-mda-2019-003 2019-01-29T11:00:32+00:00 FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive (MDA/2019/003) 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.