FDA: Recall of prefilled syringes labeled Midazolam that are actually Ondansetron
Editor's Note The FDA announced on November 3 that Fresenius Kabi USA (Lake Zurick, Illinois) is recalling one lot of Midazolam Injection, USP, 2 mg/2 mL packaged in 2 mL prefilled single-use glass syringes because the packages labeled as Midazolam actually contain syringes that are filled with and labeled as…
FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold
Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…
FDA: SCA pharmaceuticals recalls certain lots of injectable products
Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products. The recall was initiated because of the potential for the products to contain microbial contamination. Many of the recalled products are used in anesthesia,…
FDA updates Safety Alert for St Jude defibrillators
Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…
FDA alerts healthcare providers about EVAR graft endoleaks
Editor's Note The Food & Drug Administration (FDA) on September 28 sent letters to vascular and cardiothoracic surgeons, radiologists, and cardiologists, alerting them to an increase in Type III endoleaks associated with endovascular graft systems used in endovascular aneurysm repair (EVAR) for abdominal aortic and aorto-iliac aneurysms. The FDA’s letter…
FDA: Class I recall of Spectranetics’ Bridge Occlusion Balloon Catheter
Editor's Note The Food and Drug Administration (FDA) on September 25 categorized the recall by Spectranetics (Colorado Springs, Colorado) of its Bridge Occlusion Balloon Catheter (model 590-001) as Class I, the most serious. The Bridge Occlusion Balloon Catheter is used to temporarily block the superior vena cava when emergency control…
FDA updates Safety Alert for urogynecologic surgical mesh by Boston Scientific
Editor's Note The Food and Drug Administration (FDA) on September 19 updated its Safety Alert for urogynecologic surgical mesh manufactured by Boston Scientific. After an extensive review of data and testing, the FDA has determined that the change in supplier of the polypropylene used to manufacture the mesh currently on…
FDA: OriGen recalls two lots of dual lumen ECMO catheters
Editor's Note The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1). The recall was initiated because the catheters have the potential…
FDA: Class I recall of Datascope/MAQUET intra-aortic balloon pumps
Editor's Note The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious. The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump.…
FDA: Genetech recalls three lots of Activase
Editor's Note The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be…
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