FDA designates Class 1 recalls for craniotomy kit, surgical applicator, ventilators
Editor's Note The US Food and Drug Administration (FDA) has deemed Medline’s recent Craniotomy Kit recall, Integra LifeSciences’ MicroMyst Applicator recall, and Maquet Critical Care’s recent ventilator recall as Class I, the most severe category indicating serious risk of injury or death. As detailed in a July 22 FDA announcement,…
FDA designates Class I recall for manual resuscitator
Editor's Note The US Food and Drug Administration has designated SunMed Holdings, LLC’s recall of the Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing as Class I, the most severe category indicating serious risk of injury or death. The recall is due…
FDA issues early alert for microbore extension sets
Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…
FDA designates Class 1 recall for cranial drill
Editor's Note The US Food and Drug Administration (FDA) has designated Integra LifeSciences’ recall of specific Codman Disposable Perforators and Craniotomy Kits a Class 1, the most severe category indicating serious risk of injury or death. As detailed in the agency’s July 16 announcement, the recall of the single-use cranial…
FDA designates Class 1 recalls for EVH system, infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death. According to…
FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape
Editor's Note Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or…
FDA designates Class 1 recall for angiographic catheter
Editor's Note The US Food and Drug Administration (FDA) has designated Cook’s recent recall of the Beacon Tip 5.0 Fr Angiographic Catheter as a Class 1, the most severe category indicating serious risk of injury or death. The recall was reportedly motivated by reports of tip separation both prior to…
Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula
Editor's Note The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of…
FDA designates Class 1 recalls for aspiration catheter, infusion accessory, endotracheal tubes
Editor's Note The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline…
FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate
Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2, Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…
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