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Published on 24 April 2024
Contents
MHRA Device Safety Information (MDSI)
MHRA MDSI2405, Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision, issued 23 April 2024
MHRA MDSI2404, Legency Remedies 0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash: risk of microbiological contamination, issued 04 April 2024
MHRA MDSI2311U, Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection - UPDATE, issued 03 April 2024
MHRA MDSI2403, Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used, issued 25 March 2024
MHRA MDSI2402, NuVasive Specialized Orthopedics (NSO), MAGEC X System: UK suspension lifted, issued 13 March 2024
MHRA MDSI2401, Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease: update to previous MHRA guidance on use, issued 05 February 2024
MHRA MDSI2311, Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel – potential risk of infection, issued 24 November 2023
MHRA MDSI2310, SteriFeed Colostrum Collection device and risk of choking due to infant airway occlusion, issued 10 October 2023
MHRA MDSI2309, BioIntegral Surgical Inc. No-React® cardiovascular bioprosthesis implantables: discontinuation of CE marking and manufacture, issued 04 September 2023
MHRA MDSI2308, Ethypharm Aurum pre-filled syringes are incompatible with some needle-free connectors: risk of delay of potentially lifesaving medication, issued 22 August 2023
MHRA MDSI2307, EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs): update of previous quarantine advice after identification of likely cause, isssued 03 August 2023
MHRA MDSI2306, NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted, issued 13 April 2023
MHRA MDSI2305, Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica: Contamination (update to DSI/2023/002), issued 05 April 2023
MHRA MDSI2304, BD BodyGuard MicroSets and residual ethylene oxide: devices may continue to be used to treat paediatric patients 5kg and above, issued 21 February 2023
MHRA MDSI2303, Zimmer Biomet NexGen Knee replacement: affected patients should be offered additional follow up, issued 15 February 2023
MHRA MDSI2302, Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica: Contamination, issued 31 January 2023
MHRA MDSI2301, EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs): stop using immediately and quarantine all preloaded EyeCee One lenses, issued 26 January 2023
MHRA MDSI2204, Haemodialysis and haemofiltration machines: Actions to take following pressure-related alarms to avoid unintentional alteration of alarm limits, issued 22 September 2022
MHRA MDSI2203, Paclitaxel drug-coated balloons or drug-eluting stents: updated position on use in patients with critical limb ischaemia & intermittent claudication, issued 06 April 2022
MHRA MDSI2202, Surdial X Haemodialysis machine: potential for devices to remove excess fluid outside of machine specification, issued 17 February 2022
MHRA MDSI2201, Gemini Surgical UK: Stop using all lots and batches of vaginal speculums with smoke tube and gynaecological hysteroscopy sheaths, issued 17 February 2022
MHRA MDSI2110, Baihe Rheovalves disposable needle-free valves: stop using specific lots due to risk of breakage in patient, issued 21 December 2021
MHRA MDSI2109, Handpieces used in the phacoemulsification technique of cataract removal: need for careful cleaning, issued 25 November 2021
MHRA MDSI2108, Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks, issued 30 June 2021
MHRA MDSI2107, 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, issued 20 May 2021
MHRA MDSI (SC) 2106, Investigation update: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc., issued 10 May 2021
MHRA MDSI (SC) 2105, Becton Dickinson (BD) is recalling specific lots of BD Venflon Pro Safety (VPS) Needle Protected IV Cannulae after identifying an increase in reports of leakage from the injection port, issued 06 May 2021
MHRA MDSI (SC) 2104, Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal, issued 21 April 2021
MHRA MDSI (SC) 2103, Dexcom has issued a Field Safety Notice on this identified problem. Use of barrier methods or patches is not recommended as this may affect the performance of the device, issued 07 April 2021
MHRA MDSI (SC) 2102, Medoject sterile hypodermic and blunt fill needles manufactured by Chirana T. Injecta – discontinue use, issued 07 April 2021
MHRA MDSI (SC) 2101, The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia remains unchanged, issued 07 April 2021