BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class I Recall

Westmed, Inc. is initiating a nationwide recall of 24,834 units of BagEasy Manual Resuscitation Devices. Select lots of the BagEasy Device have been found to 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. This recall is classified by the FDA as Class I. Consumers who have units from the identified lots of BagEasy manual resuscitation devices which are being recalled should stop using them and return the product to Westmed or their distributor. To obtain a full listing of the part numbers and lo-t numbers, visit the FDA website (www.fda.gov), or contact Westmed customer service at 1-800-975-7987. Westmed voluntarily recalled these products after learning of units disconnecting at user facilities. The FDA has been apprised of this action. Westmed has become aware of potential for disconnection at the patient port retention during assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding unit disconnecting during setup or use. The healthcare providers obtained another unit and continued with setup or treatment. The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities. It can be identified by product labeling that contains part and lot numbers. Westmed is notifying its distributors and customers by certified mail and direct contact by sales representatives and is arranging for return of all recalled products. For more information, visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226014.htm.