Vyaire Medical, Inc. has issued a Class I recall, the most severe type, for several models of AirLife Manual Resuscitators due to a critical manufacturing flaw. The recall affects devices manufactured before 2017 or those lacking a clear production date, with over 6.6 million units recalled in the U.S. alone.
These manual resuscitators, crucial for respiratory support in emergency situations, may fail to provide adequate ventilation due to the defect. This failure can lead to hypoventilation or hypoxia, potentially resulting in severe injury or even death. So far, there have been 37 reported incidents, including two fatalities and injuries.
To address the issue, Vyaire has urged customers and distributors to immediately dispose of or destroy the affected devices and complete a Certificate of Destruction Form. These resuscitators should not be returned to Vyaire.
For further information or assistance, customers in the U.S. can contact Vyaire Medical, Inc. via email at productquality@myairlife.com. Health care professionals and consumers are also encouraged to report any adverse reactions or quality problems associated with these devices to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program