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…
FDA warns healthcare providers to conserve blood culture media bottles amid shortage
Editor's Note Healthcare providers should consider strategies to conserve BD BACTEC blood culture media bottles for patients at highest risk due to an ongoing shortage, according to a July 10 report from The US Food and Drug Administration (FDA). Attributing the shortage to supplier issues, FDA warns that the disruption…
One expert concerned over drug shortages record high
Editor's Note Erin Fox, senior pharmacy director at University of Utah Health who has been monitoring drug shortages for over 20 years, spoke to AP News in June of her concerns. Currently, the situation is worse than ever, with total active shortages hitting an all-time high of 323 (with 48…
FDA announces Class 1 recalls for ventilators, LVAS monitors
Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…
FDA issues Class 1 recalls for two ventilator models
Editor's Note Alarm failures and missing details in instructional materials 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 different ventilator models on June 27. According to the report, failure in the Ventilator Inoperative alarm…
Updated ethylene oxide sterilizer standard covers latest technology
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on ethylene oxide (EO) sterilizers for healthcare facilities, according to a June 12 press release. The first update in two decades, the fourth edition ANSI/AAMI ST24:2024 covers labeling, safety, performance, and testing requirements for general-purpose…
FDA announces Class 1 recalls for patient return electrodes, intra-aortic balloon catheters, anesthesia systems
Editor's Note The US Food & Drug Administration (FDA) has announced Class 1 recalls—the most severe category, indicating risk of serious injury or death—for three products: MEGA SOFT Pediatric Patient Return Electrodes from Megadyne, Vaporizer Sevoflurane Maquet Filling from Getinge; and Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex…
Endotracheal tube component failures prompt FDA Class I recall
Editor's Note The US Food & Drug Administration has designated Medline Industries’ recall of the Sub-G Endotracheal Tube with Subglottic Suction, which is used to keep a patients’ airway open, as a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s June…
FDA designates Class I recall for neurosurgery software
Editor's Note The US Food & Drug Administration (FDA) has classified Medtronic’s recall of its StealthStation S8 software as a Class I, the most severe category indicating risk of serious injury or death. The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during…
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…
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