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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K982215
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Product Description
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Recall
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FDA Recall
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STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer I... 2 06/01/2016 FEI # 1314417
Ventlab LLC
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, ... 1 11/01/2012 FEI # 1314417
Ventlab Corporation
A.C.E. STAT-Check CO® Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Or... 2 07/20/2004 FEI # 1314417
Ventlab Corporation
STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmH®O Pr... 2 07/20/2004 FEI # 1314417
Ventlab Corporation
STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO® Indicator, Single Pat... 2 07/20/2004 FEI # 1314417
Ventlab Corporation
STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO® Indicator, Single Patient... 2 07/20/2004 FEI # 1314417
Ventlab Corporation
STAT-Check Infant Disposable Manual Resuscitators, with 40 cmH®O Pressure Limiting System & Pressure... 2 07/20/2004 FEI # 1314417
Ventlab Corporation
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