FDA Device recall Z-1833-2022
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 G0045…
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of 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 G0045… by Cook, citing 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1833-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-16 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | TSCF-25-180-3 G01602 UDI-DI: 00827002016026 Lots/Expiration Dates: 14769750 03-06-2027 14795053 15-06-2027 14818416 29-…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: |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1833-2022%22
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