Ventlab Corporation recalls AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockvill

Recalled November 7, 2012 · FDA recall Z-0180-2013 · Ventlab

Hazard

Possible volume leakage through the inlet valve during compressions of the resuscitator bag. · FDA Class I

Units

14,602 total for all units

Sold at

Nationwide Distribution including IL, OH, NY and TN.

Description

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Product

AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Manufacturer(s)

Ventlab Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →