Feds take action on Hurricane-wracked medical supply chain with wartime powers, drug compounding guidance
Editor's Note The Biden administration has invoked wartime powers to speed rebuilding of intravenous fluid (IV) manufacturing capacity, CBS News reported October 15, four days after the US Food and Drug Administration (FDA) took steps to combat drug shortages. Both efforts are in response to devastation wrought by Hurricane Helene,…
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 announces Class 1 recall for pediatric resuscitator
Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…
FDA designates Class 1 recall for IPV therapy system
Editor's Note The US Food and Drug Administration (FDA) has deemed the recall of Sentec Percussionaire’s Phasitron 5 In-Line Valve—a component of the manufacturer’s Intrapulmonary Percussive Ventilation (IPV) therapy system—a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 2…
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…
Hurricane disrupts IV fluid manufacturing as hospitals cope with chaos
Editor's Note The shuttering of a critical Baxter International manufacturing plant in North Carolina due to Hurricane Helene could put significant stress on already strained healthcare supply chain, according to an October 1 report in Axios. According to the article, the facility is a critical production center for produces intravenous…
FDA designates Class 1 recall for tracheostomy tubes
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Smiths Medical’s Bivona Neonatal/Pediatric and Adult Tracheostomy tubes as a Class 1, the most severe category indicating risk of serious injury or death. According to the agency’s September 18 report, the recall is due to a…
FDA: Class 1 infusion system recall expanded
Editor's Note B. Braun Medical Inc. has expanded last year’s recall of lnfusomat Space Infusion Pump systems to include more models. Designated by the US Food and Drug Administration (FDA) as Class 1—the most serious category indicating risk of severe injury or death—the recall was motivated by the risk of…
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)…
Odin Medical’s AI-powered device for colonoscopy receives FDA clearance
Editor's Note Odin Medical, a subsidiary of Olympus Corporation, received Food and Drug Administration (FDA) 510(k) clearance for its cloud-based AI technology, the CADDIE™ computer-aided detection device, PRNewswire September 5 reports. Designed to assist gastroenterologists in detecting colorectal polyps during colonoscopy, the AI-powered system analyzes real-time video footage and alerts…
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