Another Class 1 Recall!

From the FDA Medwatch on 9/15:

BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall

AUDIENCE: Risk Manager, Emergency Medicine

ISSUE: Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. 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.

Recalls on the Rise?

The Class I (and some II and III) device recalls listed by FDA have gone from 18 in 2008 to 31 in 2009 to 30 to date as of 09/08/10. That begs the question are recalls on the rise? It will be interesting to see how FDA reacts to this data. Stay tuned. We will be exploring this development in weeks to come.