FDA issues Safety Alert on Lifepak 1000 defibrillators
Editor's Note The Food and Drug Administration (FDA) on January 14 issued a Safety Alert announcing the voluntary field action by Physio-Control (Redmond, Washington) notifying its customers to immediately remove and reinstall batteries in the Lifepak 1000 defibrillator. The company has received 34 reports of customers attempting to use the…
FDA: Certain Fujifilm duodenoscopes removed from clinical use
Editor's Note The Food and Drug Administration (FDA) on January 13 issued a Safety Communication that Fujifilm Medical Systems (Wayne, New Jersey) will remove its legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use. Fuji will replace the 250/450 models with the ED-530XT model,…
FDA classifies recall of IV Flush Syringes by Nurse Assist as Class I
Editor's Note The Food and Drug Administration (FDA) on January 4, 2017, classified the recall by Nurse Assist (Haltom City, Texas) of its IV Flush Syringes as Class I, the most serious. The recall was initiated because of a potential link to Burkholderia cepacia blood stream infections with the syringes.…
FDA: Class I recall of Standard Offset Cup Impactor by Greatbatch Medical
Editor's Note The Food and Drug Administration (FDA) on December 20 classified the recall by Greatbatch Medical (Frisco, Texas) of its Standard Offset Cup Impactor with a POM-C handle as Class I, the most serious. The recall was issued because the Impactor failed sterility testing when sterilized in a dedicated…
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: 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: 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…
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