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Vyaire Medical, Inc. is recalling certain AirLife manual resuscitators for a manufacturing defect that could lead to injury or death.
Using the recalled resuscitators could result in patients not receiving enough ventilation. In some cases, patients may not receive any ventilation. Patients who don’t get adequate ventilation may not be able to properly exchange oxygen and carbon dioxide (hypoventilation) or they could experience a dangerous drop in blood oxygen (hypoxia). These conditions can lead to serious injury or death.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Questions?
If you have questions about this recall, contact Vyaire Medical, Inc. at productquality@myairlife.com.
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