FDA (Devices) recall action 63347

Ventlab Corporation recalled 12 products on 2012-11-07

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2012-11-07
Critical: 0
Units: 175,224

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–12 of 12

ModerateFDA (Devices)··2012-11-07
Ventlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
Ventlab Corporation is recalling V*Care Infant Resuscitators due to a possible volume leakage through the inlet valve during compressions.
Product
V*Care Resuscitator Infant Resuscitator, VN 3000 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 r
Category
Distribution
4 states
SevereFDA (Devices)··2012-11-07
Ventlab Infant Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling 14,602 infant resuscitators due to possible volume leakage through the inlet valve during bag compressions.
Product
Ventlab Rescue Med Infant Resuscitator, 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 ass
Category
Distribution
4 states
HighFDA (Devices)··2012-11-07
Ventlab Premium Small Adult Resuscitator Recalled for Valve Leakage
Ventlab Corporation is recalling 14,602 Premium Small Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
Product
Ventlab Premium Small Adult Resuscitator, 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 a
Category
Distribution
4 states
SevereFDA (Devices)··2012-11-07
Ventlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
Ventlab is recalling 14,602 AirFlow Infant Resuscitators because the inlet valve may leak air during compressions, potentially compromising respiratory support.
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 apn
Category
Distribution
4 states
HighFDA (Devices)··2012-11-07
Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of AirFlow Small Adult Resuscitators due to possible volume leakage through the inlet valve during compressions.
Product
AirFlow, Small Adult Resuscitator, AF5000 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 reversib
Category
Distribution
4 states
HighFDA (Devices)··2012-11-07
Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during bag compressions.
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 rev
Category
Distribution
4 states
HighFDA (Devices)··2012-11-07
Ventlab Premium Small Child Resuscitator Recalled for Valve Leakage
Ventlab Corporation is recalling 14,602 Premium Small Child Resuscitators due to possible volume leakage through the inlet valve during compressions.
Product
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
Category
Distribution
4 states
SevereFDA (Devices)··2012-11-07
Ventlab AirFlow Resuscitator Recalled for Inlet Valve Leakage
Ventlab Corporation is recalling 14,602 AirFlow Resuscitators due to possible volume leakage through the inlet valve during bag compressions.
Product
AirFlow Resuscitator, Adult Resuscitator, AF1000 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 re
Category
Distribution
4 states
HighFDA (Devices)··2012-11-07
Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during use.
Product
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, 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.
Category
Distribution
4 states
HighFDA (Devices)··2012-11-07
Ventlab Pro-5000 Adult Resuscitator Recalled for Volume Leakage
Ventlab Corporation is recalling 14,602 Pro-5000 Series Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
Product
Adult Resuscitator, Pro-5000 Series, Single Patient Use, 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.
Category
Distribution
4 states
HighFDA (Devices)··2012-11-07
Ventlab Infant Resuscitator Recalled for Possible Volume Leakage
Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.
Product
Breath Tech, Safe Spot Infant Resuscitator, BT2000 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
Category
Distribution
4 states
SevereFDA (Devices)··2012-11-07
Ventlab Stat-Check Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of Stat-Check Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
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 i
Category
Distribution
4 states