Device 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 reversible apnea, commonly associated with cardiopulmonary arrest.
Z-0181-2013
Product summary
- Event
- Event 63347
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,602 total for all units
- Official record key
device-enforcement:Z-0181-2013
Official wording
Reason: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Code information: Product Code: AF5140MBPWTD5, Lot #101806 and 102163; AF5140MB-T, Lot #102075 and AFD5140MB-T, Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I, Lot #101898; AF5140MB-ST, Lot #101896; AF5140MBS, Lot #101900 and AF5140MBS-R, Lot #101899.
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.