Z-0181-2013 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2012
- Initiation Date
- July 11, 2012
- Termination Date
- June 30, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,602 total for all units
Product Description
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.
Reason for Recall
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Distribution Pattern
Nationwide Distribution including IL, OH, NY and TN.
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.