Gaps in FDA’s adverse event reporting system allowed power morcellator risks
Editor's Note A Government Accountability Office (GAO) report finds that gaps in the Food and Drug Administration’s (FDA’s) adverse event reporting system allowed the widespread use of laparoscopic power morcellators for years before their risk for spreading cancer became known, according to the February 10 Mass Device. Immediate Congressional action…
FDA: Class I recall of CareFusion Alaris Syringe Pump
Editor's Note The Food and Drug Administration (FDA) on February 9 classified the recall by CareFusion (San Diego) of its Alaris Syringe Pump (large volume pump), model 8100, and air-in-line (AIL) sensor kits as Class I, the most serious. The recall was issued because of a faulty AIL sensor, which…
FDA: Class I recall of Bard Halo One Thin-Walled Guiding Sheath
Editor's Note The Food and Drug Administration (FDA) on January 30 classified the recall by Bard Peripheral Vascular Inc (Tempe, Arizona) of its Halo One Thin-Walled Guiding Sheath as Class I, the most serious. The recall was issued because the sheath body may separate from the sheath hub while removing…
FDA: Hospira recalls one lot of Vancomycin Hydrochloride for Injection
Editor's Note The Food and Drug Administration (FDA) on January 25 announced the recall by Hospira, Inc (Lake Forest, Illinois) of one lot of Vancomycin Hydrochloride for Injection, (USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017). The recall was initiated because of a confirmed customer report of the presence of…
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…
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