Device 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 reversible apnea, commonly associated with cardiopulmonary arrest.
Z-0173-2013
Product summary
- Event
- Event 63347
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,602 total for all units
- Official record key
device-enforcement:Z-0173-2013
Official wording
Reason: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Code information: Product List 071012, Product Codes: VN3200MB, Lot #102032, VN3100MB-2, Lot #102033; VN3100MBP, Lot #102046, 102182; VN3100MB-PW2, Lot 3102050; VN3100OB, Lot #102150.
Distribution pattern: Nationwide Distribution including IL, OH, NY and TN.
Derived failure modes
-
Unknown
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.