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…
FDA announces Class 1 recalls for laryngoscopes, ventilators
Editor's Note Recalls of certain devices and instruction updates for others prompted the US Food and Drug Administration (FDA) to issue Class 1 recalls—the most severe category indicating risk of serious injury or death—for two groups of products: Medtronic’s McGrath MAC and MAC EMS Video Laryngoscopes and Breas Medical’s Vivo…
FDA announces Class 1 recall for ventilator adapter assemblies
Editor's Note The US Food and Drug Administration (FDA) designated Baxter’s recall of certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies as Class 1, the most severe recall category indicating significant risk of injury or death. The Single Patient Use Circuit and Blue Adapter Assembly are patient circuit…
FDA approves single-dose propofol amid drug shortage
Editor's Note The Food and Drug Administration (FDA) approved Amneal Pharmaceuticals' Abbreviated New Drug Application for single-dose vials of propofol injectable emulsion, Anesthesiology News August 23 reports. The newly approved formulations include 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL vials. Propofol is widely used for anesthesia and…
Some FDA-recalled medical devices remain in use while manufacturers implement corrections
Editor's Note A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend…
FDA announces Class 1 recall for chest compression devices
Editor's Note The US Food and Drug Administration (FDA) has designated Defibtech, LLC’s recall of RMU-2000 ARM XR Chest Compression Devices as Class 1, the most severe category indicating serious risk of injury or death. A motor issue could stop compressions in adults whose hearts suddenly stop, according to the…
Free Daily News
- Medical device coating could reduce blood clot risks
- FDA pilot program aims to expedite high-risk medical device recall communication
- Surgeons implant first medically suspended heart pump in US
- Study: COVID-19's impact on oncological surgery offers lessons for future crises
- Study links pandemic stress to persistent increases in nursing-sensitive quality indicators
- Save the date for the 2025 OR Business Management Conference
- Study: Education, exercise improve knee OA with or without prior surgery
- Study: Early surgery outperforms endoscopy for long-term pancreatitis
- Study: Blood thinner, NSAID combination raises bleeding risk
- Hospital financial report predicts stability, high cybersecurity costs for 2025