Cook Incorporated Recall 90793
Description: Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412 TSCF-35-145-15 G00509 TSCF-35-145-1.5 G00507 TSCF-35-145-3 G00511 TSCF-38-80-3 G00552 TSCF-18-180-3 G02160 TSCF-35-80-3 G00529 TSCF-21-180-3 G01793 TSCF-25-260-3 G00471 C-SCF-18-50-3 G02050 C-SCF-18-40-2 G02659 C-SCF-25-50-3 G02180 TSCF-18-80-3 G00441 C-SCF-15-30-2 G06973
Cook Incorporated Recall 90793 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1833-2022 |
| Event ID | 90793 |
| Event Description | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412 TSCF-35-145-15 G00509 TSCF-35-145-1.5 G00507 TSCF-35-145-3 G00511 TSCF-38-80-3 G00552 TSCF-18-180-3 G02160 TSCF-35-80-3 G00529 TSCF-21-180-3 G01793 TSCF-25-260-3 G00471 C-SCF-18-50-3 G02050 C-SCF-18-40-2 G02659 C-SCF-25-50-3 G02180 TSCF-18-80-3 G00441 C-SCF-15-30-2 G06973 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Quantity | 9,903 US; 5,185 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 | TSCF-25-180-3 G01602 UDI-DI: 00827002016026 Lots/Expiration Dates: 14769750 03-06-2027 14795053 15-06-2027 14818416 29-06-2027 TSCF-35-180-3 G00902 UDI-DI: 00827002009028 Lots/Expiration Dates: 14774744 07-06-2027 14793143 14-06-2027 14793144 14-06-2027 14795155 15-06-2027 14795156 15-06-2027 14795157 15-06-2027 14797503 16-06-2027 14798672 16-06-2027 14805743 21-06-2027 14805744 21-06-2027 14816671 28-06-2027 14821171 30-06-2027 14822357 30-06-2027 14822382 30-06-2027 14822383 30-06-2027 TSCF-21-260-3 G00455 UDI-DI: 00827002004559 Lots/Expiration Dates: 14795051 15-06-2027 14813712 27-06-2027 THSCF-25-260-3 G02384 UDI-DI: 00827002023840 Lots/Expiration Dates: 14795058 15-06-2027 TSCF-25-145-3 G00466 UDI-DI: 00827002004665 Lots/Expiration Dates: 14795071 15-06-2027 THSCF-35-80-3 G04069 UDI-DI: 00827002040694 Lots/Expiration Dates: 14797500 16-06-2027 14803099 20-06-2027 14830991 07-07-2027 14832155 07-07-2027 14837668 12-07-2027 14843270 15-07-2027 THSCF-35-180-15 G01151 UDI-DI: 00827002011519 Lots/Expiration Dates: 14798678 16-06-2027 TSCF-21-50-3 G00456 UDI-DI: 00827002004566 Lots/Expiration Dates: 14802358 20-06-2027 THSCF-35-145-3 G00412 UDI-DI: 00827002004122 Lots/Expiration Dates: 14803096 20-06-2027 TSCF-35-145-15 G00509 UDI-DI: 00827002005099 Lots/Expiration Dates: 14803101 20-06-2027 TSCF-35-145-1.5 G00507 UDI-DI: 00827002005075 Lots/Expiration Dates: 14803102 20-06-2027 TSCF-35-145-3 G00511 UDI-DI: 00827002005112 Lots/Expiration Dates: 14803184 20-06-2027 14811921 24-06-2027 14811922 24-06-2027 14811923 24-06-2027 14811924 24-06-2027 14811925 24-06-2027 14815767 27-06-2027 14815768 27-06-2027 14815769 27-06-2027 14815770 27-06-2027 14826198 05-07-2027 14826199 05-07-2027 14826200 05-07-2027 14826201 05-07-2027 14826202 05-07-2027 14831157 07-07-2027 14831158 07-07-2027 14831159 07-07-2027 14831160 07-07-2027 14831162 07-07-2027 14835711 11-07-2027 14835712 11-07-2027 14835713 11-07-2027 14835715 11-07-2027 14835716 11-07-2027 14841791 14-07-2027 14841792 14-07-2027 14843520 15-07-2027 NS14841787 14-07-2027 TSCF-38-80-3 G00552 UDI-DI: 00827002005525 Lots/Expiration Dates: 14805745 21-06-2027 NS14805905 07-07-2027 TSCF-18-180-3 G02160 UDI-DI: 00827002021600 Lots/Expiration Dates: 14807601 22-06-2027 TSCF-35-80-3 G00529 UDI-DI: 00827002005297 Lots/Expiration Dates: 14808542 22-06-2027 14808543 22-06-2027 14808544 22-06-2027 14808547 22-06-2027 14808548 22-06-2027 14814967 27-06-2027 14814968 27-06-2027 14814969 27-06-2027 14814970 27-06-2027 14814971 27-06-2027 14814972 27-06-2027 14814973 27-06-2027 TSCF-21-180-3 G01793 UDI-DI: 00827002017931 Lots/Expiration Dates: 14813705 27-06-2027 TSCF-25-260-3 G00471 UDI-DI: 00827002004719 Lots/Expiration Dates: 14818414 29-06-2027 14818415 29-06-2027 C-SCF-18-50-3 G02050 UDI-DI: 00827002020504 Lots/Expiration Dates: NS14797765 16-06-2027 NS14802360 20-06-2027 NS14818383 29-06-2027 NS14827374 05-07-2027 C-SCF-18-40-2 G02659 UDI-DI: 00827002026599 Lots/Expiration Dates: NS14802359 20-06-2027 NS14818385 29-06-2027 C-SCF-25-50-3 G02180 UDI-DI: 00827002021808 Lots/Expiration Dates: NS14818386 29-06-2027 TSCF-18-80-3 G00441 UDI-DI: 00827002004412 Lots/Expiration Dates: NS14821725 30-06-2027 C-SCF-15-30-2 G06973 UDI-DI: 00827002069732 Lots/Expiration Dates: NS14821726 30-06-2027 |
| Center Classification Date | 20220928 |
| Recall Initiation Date | 20220816 |
| Recalling Firm | Cook Incorporated |
| Initial Notification | Letter |
| Similar To |