FDA bans powdered gloves
Editor's Note The Food and Drug Administration (FDA) on December 19, 2016, published a final rule banning powdered surgeon gloves, powdered patient examination gloves, and absorbable powder for surgeon’s gloves, effective January 18, 2017. The FDA says it issued the ban because these products present unreasonable and substantial risks to…
FDA: New warning on general anesthesia and sedation in children, pregnant women
Editor's Note The Food and Drug Administration (FDA) on December 14 issued a new warning saying that repeated or lengthy use of general anesthetics and sedation drugs during surgical procedures in children younger than 3 years or pregnant women during the third trimester may affect the development of children’s brains.…
FDA: Class I recall of Centurion Convenience Kits with Multi-Med Single Lumen Catheters
Editor's Note The Food and Drug Administration (FDA) on December 9 categorized the recall by Centurion Medical Products (Williamston, Michigan) of its Centurion Convenience Kits containing Multi-Med Single Lumen Catheters as Class I, the most serious. There may be excess material at the tip of the catheters from the manufacturing…
FDA: Class I recall of SentreHeart’s FindrWIRZ Guidewire System
Editor's Note The Food and Drug Administration (FDA) on November 22 categorized the recall by SentreHeart (Redwood City, California) of its FindrWIRZ Guidewire System as Class I, the most serious. The recall was initiated because the PTFE coating may separate from the packaging and potentially cause serious injuries to patients. The…
FDA issues final rule on adverse event reporting for manufacturers
Editor's Note The Food and Drug Administration (FDA) on November 8 published its final rule on the requirements for reporting adverse events by medical device companies, the November 14 Medical Design & Outsourcing reports. The final rule walks back much of the burden for contract manufacturers that was in the…
New RBC treatment may reduce transfusion side effects
Editor's Note Pretreating red blood cells (RBCs) with nitric oxide may reduce the risk of pulmonary hypertension, a dangerous side effect of transfusions, finds this study. The Food and Drug Administration allows transfusion of RBCs that have been stored for 42 days. However, recent studies suggest that transfusion of RBCs…
FDA: Class I recall of HeartWare Ventricular Assist Device Pumps
Editor's Note The Food and Drug Administration on October 24 categorized HeartWare Inc’s recall of its HeartWare Ventricular Assist Device Pumps as Class I, the most serious. The recall is because of a design problem with the driveline connector that connects the pump to the external controller and power source.…
FDA: Class I recall of Willy Rusch Tracheostomy Tube Set
Editor's Note The Food and Drug Administration (FDA) on October 20 categorized the recall by TeleFlex Medical of its Willy Rusch Tracheostomy Tube Set as Class I, the most serious. The recall was issued because of the possibility that the connector may disconnect from the tracheostomy tube during use on…
FDA: Medtronic recalls certain neurovascular products
Editor's Note The Food and Drug Administration (FDA) on October 18 announced the recall by Medtronic of certain lots of its Pipeline embolization device, Alligator retrieval device, and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. The…
FDA: Class I recall of Skintact DF29N Multi-function Defibrillation Electrodes
Editor's Note The Food and Drug Administration (FDA) on October 14 categorized the recall by Leonhard Lang of its Skintact DF29N Multi-function Defibrillation Electrodes as Class I, the most serious. The electrode is being recalled because of a connector compatibility issue with the Welch Allyn automatic external defibrillator (AED), model…
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