Cook Incorporated Recall 90793
Description: Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
Cook Incorporated Recall 90793 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1825-2022 |
Event ID | 90793 |
Event Description | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735) |
Product Type | Devices |
Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
Quantity | 488 US, 5 OUS |
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 | TSFBP-35-180 (GPN G09782) UDI-DI 00827002097827, Lots 14797763 14797770 14805076 14805079 14813709 14813711; TSFBP-35-145 (GPN G09735) UDI-DI 00827002097353, Lots 14807595 14812037 14812038 |
Center Classification Date | 20220928 |
Recall Initiation Date | 20220816 |
Recalling Firm | Cook Incorporated |
Initial Notification | Letter |
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