Z-0175-2013 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 Resuscitator, Adult Resuscitator, AF1000 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 List 071012, Product Code: AF1040MB, Lot #102091 and 102191; AF1040MBP, Lot #102106 and 102174; AF1040MBS, Lot #102189, AF1040MB-S5, Lot #102105, AF1040MB-T, Lot #101917 and 102151; AF1100MB, Lot #102227, AF1140MB, Lot #102081 and 102139, AF1140MB-K, Lot #102093 and 102165; AF1140MB-P5, Lot #102145; AF1140MBP-T, Lot #102096 and Product Code: AF1140MB-T, Lot #101666.