Details of UK MHRA’s alert relating to St Jude’s Riata defibrillator leads.
Alerts/Adverse Events
Medical Device Alert: Smiths Medical Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes
UK MHRA has issued a Medical Device Alert relating to Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes manufactured by Smiths Medical.
Medical Device Alert: Octopus 3 Extension Set With Antireflux Valves And Clamps Manufactured By Vygon
UK MHRA has issued a Medical Device Alert(MDA) relating to Vygon’s Octopus 3 extension set with antireflux valves and clamps, which have been identified as at possible risk of failure to deliver therapy under gravity infusion.
PIP: One Bad Apple?
While we can all point fingers at the PIP breast implant situation as being a one-off, all parties must look in the mirror to ensure this is used as a lesson in how things can go wrong.
PIP Breast Implants: How Did This Happen?
medlatest speculates about whether regulatory controls are tight enough when a company can substitute “mattress grade” silicone for that which was approved in the regulatory process.
St Jude Riata Voluntary Recall Judged By FDA as Class 1
12 months after European regulators issued alerts, St. Jude Medical, Inc. has now announced that following its voluntary medical device advisory letter to physicians from Nov. 28, 2011 the U.S. Food and Drug Administration (FDA) has now classified this action as a Class I Recall.
Medical Device Alert: Molnlycke Health Care ProcedurePaks®
UK MHRA has issued a Medical Device Alert relating to Molnlycke Health Care ProcedurePaks® with devices containing latex, which have been labelled as latex-free.
Medical Device Alert: Auxiliary Common Gas Outlet on Aestiva, Aisys, Aespire and Avance Anaesthetic Machinesed by Lifecare Hospital Supplies Ltd
UK MHRA has issued a Medical Devices Alert(MDA) relating to the Auxiliary Common Gas Outlet (ACGO) on all Aestiva, Aisys, Aespire and Avance anaesthetic machines manufactured by GE Healthcare.
Medical Device Alert on Venturi Air Entrainment Jet Adapters manufactured by Lifecare Hospital Supplies Ltd
UK MHRA has issued a Medical Devices Alert on Venturi Air Entrainment Jet Adapters supplied in kits with Oxygen facemasks and Tubing, manufactured by Lifecare Hospital Supplies Ltd.
Medical Device Alert on Crystal® Metal Disposable Laryngoscope Blades
Medical Device Alert: Crystal® Metal disposable laryngoscope blades (size Mac 4) manufactured by Penlon Ltd (MDA/2011/101)
Medical Device Alert on Aquarius Haemofiltration Device
UK MHRA has issued a Medical Device Alert (MDA) on the Aquarius Haemofiltration Device manufactured by Nikkiso Europe GmBH and distributed by Baxter Healthcare.