BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall
MedSun: Newsletter #53, October 2010

FDA MedWatch Safety Alert

Certain units of the BagEasy device have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation.

Additional Information:

FDA MedWatch Safety Alert. BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall. September 15, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226014.htm


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