Cook Incorporated Recall 90793
Description: Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
Cook Incorporated Recall 90793 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1835-2022 |
| Event ID | 90793 |
| Event Description | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Quantity | 25 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 | THDOC-35-60-0-3 G11949 UDI-DI: 00827002119499 Lots/Expiration Dates: 14797780 16-06-2027 C-HDOC-18-40-0-2 G09201 UDI-DI: 00827002092013 Lots/Expiration Dates: NS14807603 22-06-2027 C-THDOC-18-40-0-2-HTS G26925 UDI-DI: 00827002269255 Lots/Expiration Dates: NS14818388 29-06-2027 |
| Center Classification Date | 20220928 |
| Recall Initiation Date | 20220816 |
| Recalling Firm | Cook Incorporated |
| Initial Notification | Letter |
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