FDA classifies Vyaire recall as ‘most serious’
The FDA has issued a Class I recall for Vyaire Medical respiratory support devices, saying use of older, defective devices could result in injury or death.
Vyaire itself initiated a recall last December of certain models of its AirLife Manual Resuscitators, recalling more than 6.6 million devices nationwide. Due to a manufacturing defect, older models of the resuscitators have been found to deliver inadequate ventilation or none at all. There have been 37 reported incidents, including two deaths, related to the recalled resuscitators, according to the FDA.
While the defect was correct in 2017, devices manufactured before that date still pose a risk. The FDA directed providers to a Jan. 10 communication sent to Vyaire customers and said providers and distributors should immediately discard or destroy the impacted devices and notify the company.
A full list of impacted product codes is available here.
Evan joined TriMed in 2011, writing primarily for Health Imaging. Prior to diving into medical journalism, Evan worked for the Nine Network of Public Media in St. Louis. He also has worked in public relations and education. Evan studied journalism at the University of Missouri, with an emphasis on broadcast media.