BagEasy Manual Resuscitation Device Recall Issued Due to Defect

About 24,000 BagEasy resuscitation devices have been recalled because they could break while rescue workers are trying to use them to save lives. 

The FDA announced a BagEasy Manual Resuscitation Device recall on September 14 after the manufacturer, Westmed, Inc., reported that healthcare providers at three separate facilities had the devices fail on them during setup or use. In all three cases the healthcare providers were able to obtain another device and continue with treatment.

According to the manufacturer, a retention ring on the device can fail, causing it to be inoperable. This can cause a delay in a resuscitation attempt on a patient while healthcare professionals or emergency technicians get another device. The FDA has classified the resuscitator recall as a Class I medical device recall, the most serious category of medical device recall.

The recall affects 24,384 BagEasy Manual Resuscitation Devices. They were sold directly from Westmed to hospitals and care facilities, and through distributors. The recall includes 13 models of manual resuscitators, for adults, children and infants. A full list of models and lot numbers are available in on the recall press release.

Westmed has alerted distributors and customers by mail to arrange for return of the products. Anyone experiencing problems with the device are asked to report the incident to the FDA’s MedWatch Program at http://www.fda.gov/safety/medwatch/default.htm.