FDA announces Class 1 recall for Draeger breathing filters
Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…
Soap recalled due to to bacterial contamination
Editor's Note DermaRite Industries has voluntarily recalled multiple lots of healthcare products nationwide due to contamination with Burkholderia cepacia, a bacterium that poses serious infection risks to immunocompromised individuals, according to an August 10 article in Newsweek. The recall affects four product lines commonly used in healthcare settings for handwashing…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
FDA designates Class I recall for disposable surgical stapler cartridge correction
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement, the recall…
FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
FDA designates Class I recall for mobile lift component
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
FDA issues safety alert for Baxter Novum IQ large volume pumps
Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus). According to the agency’s July 22…
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…
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