Enforcement Report - Week of November 7, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-0175-2013 |
| Classification | Class I |
| Code Info | 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. |
| Product Distributed Qty | 14,602 total for all units |
| Reason For Recall | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
Event Detail
| Event Id | 63347 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Ventlab Corporation |
| City | Mocksville |
| State | NC | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including IL, OH, NY and TN. |
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