Ventlab Adult and Pediatric Manual Resuscitators: Recall
MedSun: Newsletter #80, January 2013

FDA MedWatch Safety Alert

The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of airflow to the patient may not be easily observable to the user because the bag still deflates when compressed. Lack of air/oxygen can cause life-threatening health consequences for patients, including hypoxia, hypoventilation or death.

Additional Information:

FDA MedWatch Safety Alert. Ventlab Adult and Pediatric Manual Resuscitators: Recall. December 21, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333261.htm