Cook Medical Kwart Retro-Inject Ureteral Stent Set 7 — Class II medical device recall Z-0960-2021
Terminated recall by Cook Inc., reported 2021-02-17, distributed in FL, KY, MD, NY, PA, TX. Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible
| Recall number | Z-0960-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2021-01-04 |
| Classified | 2021-02-05 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2021-09-16 |
| Distributed | FL, KY, MD, NY, PA, TX |
| Countries outside the US | CA, CH |
| Quantity | 42 units |
| Reason classes | specification failure, device malfunction |
| UPC / GTIN / UDI-DI | 00827002148376 |
| Lot numbers | 13024536, 13089895, NS13089897 |
| Model numbers | 003700, G14837 |
Product
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
Reason for recall
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
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-0960-2021. 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.