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 to incorrect assembly of the B/V filter, which can result in hypoxia, hypercapnia, organ failure, and death, FDA reports. No injuries or deaths have been reported. The manufacturer recommends stop using, quarantine, and return or destroy all affected units. Full details, including UDIs and serial numbers are available in FDA’s full July 18 announcement.