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MHRA Medical Device Safety Information – MDSI2403

MDSI2403 - Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used.

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This guidance is intended to support safe and effective medical devices and equipment risk management practice in health and social care services.

MDSI2405 - Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision

SAN2302 - Reinforced autoclaved aerated concrete (RAAC) planks in building roofing, walls, and flooring: risk of catastrophic structural failure

NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis.

EFN2101 - DiversiTech (Pump House Ltd) PAC12 & PAH12 portable air conditioners containing R290 Refrigerant: risk of fire

MDSI2110 - Baihe Rheovalves disposable needle-free valves: stop using specific lots due to risk of breakage in patient

Some medicines for inherited metabolic disorders (IMD) are funded by this risk share scheme nationally. Learn more about them.

Details about the vision, mission and purpose of the NHSScotland Counter Fraud Strategy 2023-2026