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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The hazard is a mechanical defect (volume leakage) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ventlab Corporation is recalling specific lots of V*Care Resuscitator Infant Resuscitators, VN 3000 Series. The recall involves 14,602 units that were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee.
The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could affect the device's ability to provide proper respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Healthcare facilities and consumers should stop using the affected units immediately. The specific product codes and lot numbers involved are VN3200MB (Lot #102032), VN3100MB-2 (Lot #102033), VN3100MBP (Lot #102046, 102182), VN3100MB-PW2 (Lot 3102050), and VN3100OB (Lot #102150).
The recalled product
- 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
- Manufacturer
- Ventlab Corporation
- Affected units
- 14,602
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Product List 071012
- Product Codes: VN3200MB
- Lot #102032
- VN3100MB-2
- Lot #102033
- VN3100MBP
- Lot #102046
- 102182
- VN3100MB-PW2
- Lot 3102050
- VN3100OB
- Lot #102150.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Ventlab Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Ventlab Corporation
See all →- SevereVentlab Infant Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
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- HighVentlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
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