FDA: Class I recall of Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit

Editor's Note

The Food and Drug Administration (FDA) on May 11 announced the Class I recall, the most serious, of Vyaire Medical Inc's (Lake Forest, Illinois) AirLife Resuscitation Device & Broselow Convenience Kit.

The recall was initiated because of an error in product design that may result in difficulty or the inability to disconnect the mask from the elbow of the resuscitator.

Difficulty disconnecting the mask could result in a delay in or inability to provide necessary ventilation and potentially result in serious patient injury, such as hypoxia, or death.