Enforcement Report - Week of July 5, 2012
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Event Detail
| Event ID | 62272 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | SALTER LABS |
| City | Arvin |
| State | CA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-30 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Nationwide distribution: USA including states of: FL, IN, KS, PA and TX. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia. | Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612. | Class II | A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector. | 242 cases | Z-1898-2012 |
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