Enforcement Report - Week of November 7, 2012
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Product Detail
| Product Description | Safe Spot Infant Resuscitator, SS3200 Series, Single Patient 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-0170-2013 |
| Classification | Class I |
| Code Info | Product List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253. |
| 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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