FDA Enforcement
Class I
Terminated
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.
Recall: Z-0178-2013
·
Reported November 7, 2012
Enforcement
- Recall Number
- Z-0178-2013
- Event ID
- 63347
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ventlab Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 7, 2012
- Initiation Date
- July 11, 2012
- Classification Date
- November 1, 2012
- Termination Date
- June 30, 2013
- Address
- 155 Boyce Dr, N/A, Mocksville, NC, 27028-4187, United States
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.
Reason
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Code Info
Product Code: VN500MX, Lot #102194.
Distribution
Nationwide Distribution including IL, OH, NY and TN.
Quantity
14,602 total for all units