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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