Fixed Core Wire Guide — Class I medical device recall Z-0399-2021
Terminated recall by Cook Inc., reported 2020-11-11, distributed in AZ, IA, IN, MA, ND. Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence o
| Recall number | Z-0399-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2020-10-22 |
| Classified | 2020-11-03 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2021-09-02 |
| Distributed | AZ, IA, IN, MA, ND |
| Quantity | 61 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 00827002005174 |
| Lot numbers | 13199931 |
Product
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
Reason for recall
Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
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-0399-2021. 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.