tag:www.gov.uk,2005:/drug-device-alerts 2024-10-02T12:03:28+01:00 HM Government 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 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

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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.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

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

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

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/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

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/paclitaxel-coated-devices-pcd-used-in-the-treatment-of-peripheral-arterial-disease-update-to-previous-mhra-guidance-on-use-where-indicated-pcd-can-be-considered-as-a-treatment-option-for-both-critical-limb-ischaemia-cli-and-interm 2024-02-05T13:37:23+00:00

Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD).

tag:www.gov.uk,2005:/drug-device-alerts/specific-brands-of-carbomer-eye-gel-recall-of-aacarb-eye-gel-aacomer-eye-gel-and-puroptics-eye-gel-potential-risk-of-infection-dsi-slash-2023-slash-11 2023-11-24T11:03:47+00:00

Specific batches of carbomer gel are being recalled as a precaution due to possible microbiological contamination.

tag:www.gov.uk,2005:/drug-device-alerts/no-react-r-cardiovascular-bioprosthesis-implantables-discontinuation-of-ce-marking-and-manufacture-remaining-stock-may-continue-to-be-used-and-any-adverse-incidents-reported-nationally-dsi-slash-2023-slash-009 2023-09-04T14:00:33+01:00

The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing.

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

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/ethypharm-aurum-pre-filled-syringes-are-incompatible-with-some-manufactured-needle-free-connectors-risk-of-delay-in-administering-potentially-lifesaving-medication-dsi-slash-2023-slash-008 2023-08-22T11:51:33+01:00

Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille�

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

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

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

Pharmaswiss ÄŚeska 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/nuvasive-specialized-orthopedics-nso-precice-titanium-systems-uk-suspension-lifted-dsi-2023-slash-006 2023-04-12T09:59:41+01:00

The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte �

tag:www.gov.uk,2005:/drug-device-alerts/belzer-uw-cold-storage-solution-and-belzer-mps-uw-machine-perfusion-solution-manufactured-by-carnamedica-ukrp-bridge-to-life-contamination-of-fluid-update-to-dsi-slash-2023-slash-002-dsi-slash-2023-slash-005 2023-04-04T11:02:14+01:00

The MHRA is providing an update on defects identified with Belzer solutions, manufactured by Carnamedica (UK Responsible Person Bridge to Life).

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

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/belzer-uw-cold-storage-solution-and-belzer-mps-uw-machine-perfusion-solution-manufactured-by-carnamedica-ukrp-bridge-to-life-contamination-of-fluid-dsi-slash-2023-slash-002 2023-01-31T15:31:47+00:00

Carnamedica has identified issues with third-party suppliers, which could result in microbiological contamination, particulate matter within the solution, and leakage of fluid.

tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notice-26-january-2023 2023-01-26T10:45:18+00:00

Field Safety Notices (FSNs) from 26 January 2023.

tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-21-to-25-november-2022 2022-11-28T15:34:54+00:00

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

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

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

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

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

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/rheovalves-disposable-needle-free-valves-stop-using-specific-lots-due-to-risk-of-breakage-in-patient-dsi-slash-2021-slash-010 2021-12-20T16:02:36+00:00

Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk of the device breaking in use.

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

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/handpieces-used-in-the-phacoemulsification-technique-of-cataract-removal-need-for-careful-cleaning-dsi-slash-2021-slash-009 2021-11-24T09:51:01+00:00

Residue particles can end up in the patient’s eye. For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-vygoris-limited-mitocin-mitomycin-20mg-powder-for-solution-for-injection-slash-infusion-or-intravesical-use-el-21-a-slash-27 2021-11-08T11:34:13+00:00

Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution (&gt�

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

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

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

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/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

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

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/recall-of-bd-venflon-pro-safety-iv-cannula 2021-05-20T11:14:17+01:00

Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.

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

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

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

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

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/philips-sterilizable-defibrillator-internal-paddles-specific-models-may-fail-to-deliver-therapy-if-pre-use-checks-are-not-followed 2020-07-23T13:00:50+01:00

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.

tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-xl-defibrillator-monitor-therapy-selector-switch-may-fail-mda-2020-018 2020-06-30T10:00:03+01:00

Manufactured by Philips � the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.

tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-mrx-monitor-defibrillators-may-fail-to-deliver-therapy-without-alerting-the-user-to-a-fault-in-the-event-of-internal-damage-mda-2020-016 2020-06-17T14:01:13+01:00

The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

tag:www.gov.uk,2005:/drug-device-alerts/anaesthetic-machines-off-label-use-during-the-covid-19-pandemic-mda-2020-012 2020-04-08T16:20:58+01:00

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.

tag:www.gov.uk,2005:/drug-device-alerts/spinal-implant-all-magec-systems-supply-suspended-to-the-uk-mda-2020-011 2020-04-01T15:15:14+01:00

Manufactured by NuVasive Specialized Orthopedics � supply of all MAGEC rods suspended to the UK market during a review by MHRA.

tag:www.gov.uk,2005:/drug-device-alerts/spinal-implant-magec-system-model-x-rods-risk-of-failure-in-use-mda-2020-010 2020-03-18T14:09:20+00:00

Manufactured by NuVasive Inc. � risk of end cap separation after implantation.

tag:www.gov.uk,2005:/drug-device-alerts/various-olympus-duodenoscope-models-do-not-use-if-elevator-wires-are-frayed-or-damaged-as-these-may-cause-lacerations-to-patients-and-users 2020-02-27T12:01:49+00:00

Manufactured by Olympus Medical Systems Corp � instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.

tag:www.gov.uk,2005:/drug-device-alerts/britepro-solo-and-briteblade-pro-single-use-fibre-optic-laryngoscope-blades-and-handles-risk-of-choking-mda-2019-044 2019-12-12T12:29:26+00:00

Manufactured by Flexicare Medical � loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.

tag:www.gov.uk,2005:/drug-device-alerts/professional-use-defibrillator-monitor-efficia-dfm100-model-number-866199-risk-of-failure-to-switch-on-or-unexpected-restart 2019-10-31T12:00:05+00:00

Manufactured by Philips � due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.

tag:www.gov.uk,2005:/drug-device-alerts/intraoperative-probe-cover-with-long-surgi-tip-risk-of-infection-due-to-manufacturing-failure-specific-lot-numbers-affected-mda-2019-034 2019-10-09T11:00:18+01:00

Manufactured by Ecolab/Microtek Medical Malta Ltd � bacterial contamination may cause an infection in patients.

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

GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.