Resuscitator Recall Caused by Valve Leak

January 11, 2013
Mocksville, N.C.-based Ventlab is recalling adult and pediatric disposable manual resuscitators due to a potential valve leak that could affect the flow of oxygen to the patient. The problem is hard to detect because the resuscitator still deflates when compressed, the Class I recall notice states. Customers should return resuscitators distributed between March and July 2012 for replacement. The models and serial numbers of affected units are on the FDA website.
Devices & Diagnostics Letter