FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators
Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…
FDA designates Class 1 recall for infusion pumps due to air bubble risk
Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to a defect in…
FDA designates Class 1 recalls for infusion pump software, ventilator software
Editor's Note The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death. According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion…
FDA designates Class 1 recall for infusion system components
Editor's Note The US Food and Drug Administration (FDA) has designated Fresenius Kabi’s recall of certain Ivenix infusion system components as Class 1, the most severe category indicating risk of serious injury or death. According to the agency’s September 16 announcement, the recalled items consist of a certain lot (3010538)…
Battery problem prompts FDA Class 1 recall for infusion pumps
Editor's Note The US Food and Drug Adminstration (FDA) has classified a recall of ICU Medical’s Plum 360, Plum A+ and Plum A+3 infusion pumps as Class 1, the most severe category indicating risk of serious injury or death. According to he agency’s August 20 announcement, the company is updating…
Study: Intraoperative DEX infusions effectively manage diabetes in cardiac surgery patients
Editor's Note Intraoperative infusion of dexmedetomidine (DEX) could help improve glycemic control and reduce insulin requirements in diabetic patients undergoing cardiac surgery, according to a July 25 article in Medical Dialogues. The article focuses on a prospective observational study published in the journal Annals of Cardiac Anesthesia. The study included…
Class 1 recall announced for ambulatory infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s May 30 announcement, the company recalled the pumps in direct…
FDA announces class 1 recalls for infusion pumps, anesthesia workstation
Editor's Note Reports of spontaneous backup battery failure in Dreager Inc.’s Perseus A500 anesthesia workstation and multiple failures in InfuTronix, LLC’s Nimbus infusion pump systems prompted the FDA to classify manufacturer recalls as class 1, the most serious categorization indicating risk of serious harm or death. According to an April…
FDA announces class 1 recalls for premixed embolic, infusion pump software
Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…
FDA: Class I recall of certain ICU Medical infusion system batteries
Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…
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