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 warns of allergic reactions to CHG
Editor's Note The Food and Drug Administration (FDA) on February 2 issued a warning that rare but serious allergic reactions have been reported with use of chlorhexidine gluconate (CHG). The FDA is requesting that manufacturers add a warning label about this risk to over-the-counter (OTC) products containing CHG. CHG is…
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 Communication on ED-3490TK duodenoscope by Pentax
Editor's Note The Food and Drug Administration (FDA) on January 17 issued a Safety Communication to inform Pentax ED-3490TK video duodenoscope users of updated recommendations to help prevent the spread of infection associated with the use of these devices. Since a February 19, 2016, Safety Communication to inform users about…
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 issues safety alert on implantable cardiac devices, transmitters by St Jude Medical
Editor's Note The Food and Drug Administration on January 9 issued a safety alert for St Jude Medical’s (St Paul, Minnesota) radio frequency-enabled implantable cardiac devices and Merlin@home transmitters on reducing the risk of patient harm from cybersecurity vulnerabilities. The vulnerabilities, if exploited, could allow an unauthorized user to remotely…
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.…
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