Enforcement Report - Week of November 7, 2012
-
Back to Previous Page
Product Detail
| Product Description | Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 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-0172-2013 |
| Classification | Class I |
| Code Info | Product List 071012, Product Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193. |
| 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. |
-
