Vyaire Medical is recalling certain AirLife Manual Resuscitators due to a manufacturing defect that could result in patients not receiving enough ventilation.
In some cases, patients may not receive any ventilation. People who don’t get adequate ventilation may not be able to properly exchange oxygen and carbon dioxide (hypoventilation) or they could experience a drop in blood oxygen (hypoxia). These conditions can lead to serious injury or death.
The Airlife Manual Resuscitator is a single patient use resuscitator intended for respiratory support. There have been 37 reported incidents related to the recalled AirLife resuscitators, including two injuries and two deaths.
Vyaire sent customers and distributors an urgent customer notification letter. The letter asked customers with AirLife manual resuscitators impacted by the recall to:
- Discard or destroy the recalled AirLife manual resuscitators
- Complete a Certificate of Destruction Form and return it to Vyaire
- Recalled resuscitators should not be returned to Vyaire
The issue was traced to a manufacturing defect that was corrected in 2017, but resuscitators distributed before the correction may still be in use. According to the FDA, the recall includes 6,633,173 devices in the U.S. The agency has classified the recall as a Class 1 recall, indicating that use of these devices may cause serious injuries or death.
