FDA: Addition to Class I recall of LivaNova LifeSPARC System Controller
Editor's Note The Food and Drug Administration (FDA) on January 27 posted an addition to the Class I recall by LivaNova (TandemLife) of its LifeSPARC System Controller. The addition to the recall provides information about a software update now available to address the previous software malfunction and recall. The System…
Study: Unsafe medical devices gain FDA approval through loophole
Editor's Note A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing…
FDA: Class I recall of Datascope/Getinge Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA) on January 25 identified the recall by Datascope/Gettinge of its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the risk that blood may enter the pump through a damaged balloon…
FDA: Class I recall of Arrow AutoCAT2, AC3 IABPs
Editor's Note The Food and Drug Administration (FDA), on December 20, identified the recall by Arrow International, LLC, subsidiary of Teleflex, Inc, of its Arrow AutoCAT 2 and AC3 intra-aortic balloon pumps (IABPs) as Class I, the most serious. IABPs are used in patients having cardiac and non-cardiac surgery, and…
FDA: Class I recall of Thermo Scientific Gram Negative IVD AST Sensititre Plate
Editor's Note The Food and Drug Administration (FDA) on December 9 identified the recall by Remel, Inc, of its Thermo Scientific Gram Negative IVD AST Sensititre Plate as Class I, the most serious. The Plates are used to test the susceptibility of Gram-negative bacterial infections to specific antibiotics. The recall…
FDA: Class I recall of Dewei Medical Equipment’s DNA/RNA Preservation Kits
Editor's Note The Food and Drug Administration (FDA) on December 8 identified the recall by Dewei Medical Equipment Co of its DNA/RNA Preservation Kits as Class I, the most serious. The kits are used to collect, preserve, and transport clinical samples that will be tested for viruses, including COVID-19. The…
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