Nearly 25,000 units of BagEasy Manual Resuscitation Devices are being recalled by the manufacturer, Westmed, Inc., because of a defect that could render the devices inoperable and potentially result in a delay of treatment in patients. The recall is categorized by the Food and Drug Administration (FDA) as Class 1, a classification set aside for dangerous or defective products that have a strong probability of causing serious health problems or death.

The nationwide recall involves 24,348 devices distributed to medical device distribution companies as well as directly to hospitals and other treatment facilities. The lots in question 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 can result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. Consumers who have units from the recalled lots should stop using them and return the product to Westmed or their distributor. 

The recall includes the following part numbers and lot numbers:

Westmed is notifying its customers and distributors by certified mail and through direct contact by sales representatives and is arranging for the return of all recalled products. Customers with questions may contact the company at 1-800-975-7987 Monday through Friday from 6 a.m. until 5 p.m. Arizona Standard Time. Any adverse events with this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.