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 associated with cardiopulmonary arrest.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: VN500MX, Lot #102194.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ventlab Corporation
- Reason for Recall:
- Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 associated with cardiopulmonary arrest.
Product Codes/Lot Numbers:
Product Code: VN500MX, Lot #102194.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0178-2013
Related Recalls
Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.
The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.