FDA: Class I recall of Getinge/Datascope/Maquet Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
Editor's Note The Food and Drug Administration, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The IABPs are cardiac assist devices used in patients having cardiac and noncardiac surgery and to treat patients…
FDA: Edge Pharma issues nationwide recall of all drug products
Editor's Note The Food and Drug Administration (FDA) on December 7 announced that Edge Pharma, LLC (Colchester, Vermont) has issued a nationwide recall of all drug products. The recall was initiated because of process issues that could lead to a lack of sterility assurance for products intended to be sterile…
FDA: Class I recall of Teleflex percutaneous thrombolytic device kit
Editor's Note The Food and Drug Administration (FDA), on November 30, identified the worldwide recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as Class I, the most serious. The device, which is used for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts, was…
FDA: Nationwide recall of certain SterRx drug products
Editor's Note The Food and Drug Administration (FDA), on November 15, announced the nationwide recall by SterRx, LLC, of 240 lots of its drug products. The recall was initiated because of the lack of sterility assurance due to equipment and process issues. The recalled drugs include: l mg/ml Midazolam in…
FDA: Class I recall of Aligned Medical Solutions custom convenience kits
Editor's Note The Food and Drug Administration (FDA), on November 9, identified the recall by Aligned Medical Solutions of its custom convenience kits as Class I, the most serious. The recall was initiated because of the potential for the plunger in Cardinal Health's Monoject Flush Prefilled Syringe (0.9% sodium chloride),…
FDA investigating imported surgical, exam gloves
Editor's Note The Food and Drug Administration (FDA), on September 29, announced that healthcare facilities and providers should not purchase or use imported surgical and patient examination gloves from companies included on Import Alert 80-04. Companies are listed on an import alert when the FDA has enough evidence that they…
FDA: Class I recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs
Editor's Note The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious. The recall was initiated because of the risk of the battery failing and having a shortened run time, which…
FDA: Class I recall of DeRoyal procedure packs containing Smiths Medical Normoflo irrigation warming sets
Editor's Note The Food and Drug Administration (FDA), on October 6, identified the recall by Deroyal Industries of its procedure packs containing Smiths Medical Normoflo irrigation warming sets as Class I, the most serious. The recall was initiated because of the possibility of harmful levels of aluminum leaching into the…
FDA: Class I recall of Imperative Care ZOOM 71 Reperfusion Catheter
Editor's Note The Food and Drug Administration (FDA) on October 6 identified the recall by Imperative Care Inc of its ZOOM 71 Reperfusion Catheter as Class I, the most serious. The ZOOM 71 Reperfusion Catheter is used to remove blood clots from a patient’s brain within 8 hours of an…
FDA: Class I recall of Amsorb Plus used to absorb carbon dioxide in anesthesia machines
Editor's Note The Food and Drug Administration (FDA), on September 23, identified the recall by Armstrong Medical of certain lots of its Amsorb Plus Prefilled G-Can 1.0L canisters as Class I, the most serious. Amsorb Plus is a chemical substance used in anesthesia machines to absorb carbon dioxide the patient…
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