Ventlab Corporation

FDA Regulatory Profile

Summary

Total Recalls
12 (12 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0176-2013Class ISafe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable ResuscitatorJuly 11, 2012
Z-0171-2013Class IAdult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optiJuly 11, 2012
Z-0181-2013Class IAirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, July 11, 2012
Z-0180-2013Class IAirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 BJuly 11, 2012
Z-0170-2013Class ISafe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab CorporatiJuly 11, 2012
Z-0179-2013Class IVentlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, MockvJuly 11, 2012
Z-0178-2013Class IVentlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, MocJuly 11, 2012
Z-0173-2013Class IV*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab CorporJuly 11, 2012
Z-0174-2013Class IBreath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab CorpJuly 11, 2012
Z-0175-2013Class IAirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab CorporJuly 11, 2012
Z-0172-2013Class IStat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, July 11, 2012
Z-0177-2013Class IVentlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, MocJuly 11, 2012