Cook Incorporated Recall 90793
Description: Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Cook Incorporated Recall 90793 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1836-2022 |
| Event ID | 90793 |
| Event Description | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Quantity | 42 US |
| Recall Reason | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. |
| Device Classification | 20221005 |
| Device Code Info | TSFNA-35-145 G00701 UDI-DI: 00827002007017 Lots/Expiration Date: 14798674 16-06-2027 TSCFNA-35-145-3 G00561 UDI-DI: 00827002005617 Lots/Expiration Date: 14835600 11-07-2027 |
| Center Classification Date | 20220928 |
| Recall Initiation Date | 20220816 |
| Recalling Firm | Cook Incorporated |
| Initial Notification | Letter |
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