Fixed Core Wire Guide — Class II medical device recall Z-1834-2022
Ongoing recall by Cook Incorporated, reported 2022-10-05, distributed nationwide. Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron s
| Recall number | Z-1834-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2022-08-16 |
| Classified | 2022-09-28 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00827002005877, 00827002005907, 00827002005938, 00827002006027, 00827002006171, 00827002006386, 00827002006508, 00827002006522, 00827002006645, 00827002012370, 00827002019379, 00827002019386, 00827002021631, 00827002022553, 00827002022614, 00827002022744, 00827002023512, 00827002024083 |
| Lot numbers | 14-07-2027, 14795056, 14795057, 14795061, 14795064, 14795595, 14795596, 14797774, 14798256, 14798673, 14798677, 14802345, 14802352, 14802353, 14807597, 14809677, 14809679, 14809680, 14813708, 14816669, 14821167, 14821721, 14821849, 14821850, 14821851, 14821852, 14821853, 14821854, 14821855, 14822385, 14827347, 14827348, 14827349, 14827350, 14827351, 14827352, 14827353, 14827354, 14827355, 14827356 and 72 more |
| Model numbers | C-SF-15-50, C-SF-18-30, C-SF-18-40, C-SF-21-30, C-SF-25-30, C-SF-25-40, C-SF-25-50, G00587, G00590, G00593, G00602, G00617, G00638, G00650, G00652, G00664, G01237, G01937, G01938, G02163, G02255, G02261, G02274, G02351, G02408 and 11 more |
Product
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593 TSF-35-145 G00650 TSF-21-145 G00602 THSF-35-180 G01237 TSF-35-80 G00664 C-SF-25-30 G02163 C-SF-21-30 G02351 THSF-35-80 G02408
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1834-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.