Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

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Editor's Note The US Food and Drug Administration (FDA) designated Class 1 Recalls—the most severe category indicating serious risk of injury or death—for multiple devices over the past few days, including pressure monitoring systems, emergency resuscitators, fluid delivery sets, extracorporeal blood circuits, endoscope accessories, infusion pumps, and glucose/Ketone meters. These…

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Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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Editor's Note The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death. The product is designed to administer…

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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…

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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…

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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…

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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…

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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…

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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…

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