FDA Device recall Z-1825-2022
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire 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-1825-2022 |
| 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
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)
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 | TSFBP-35-180 (GPN G09782) UDI-DI 00827002097827, Lots 14797763 14797770 14805076 14805079 14813709 14813711; TSFBP-35-…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 |
|---|
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-1825-2022%22
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