Enforcement Report - Week of November 7, 2012
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Product Detail
| Product Description | Breath Tech, Safe Spot Infant Resuscitator, BT2000 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-0174-2013 |
| Classification | Class I |
| Code Info | Code: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081. |
| 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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