Ventlab Corporation recalls Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive,

Recalled November 7, 2012 · FDA recall Z-0170-2013 · 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

Safe Spot Infant Resuscitator, SS3200 Series, Single Patient 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 →