Ventlab Corporation recalls Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Sing

Recalled November 7, 2012 · FDA recall Z-0172-2013 · 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

Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 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 →