C-Flex Double Pigtail Ureteral Stent Set — Class II medical device recall Z-0973-2020
Terminated recall by Cook Inc., reported 2020-02-12, distributed nationwide. The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guid
| Recall number | Z-0973-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-01-04 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2020-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BO, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FR, GB, GT, HN, HR, HU, IE, IN, IT, JP, KR, LU, MT, MX, MY, NL, NZ, OM, PA, PL, PY, RO, SE, TT, TW, ZA |
| Quantity | 13,388 total |
Product
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Reason for recall
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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-0973-2020. 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.