FDA Device recall Z-0960-2021
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotrip…
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotrip… by Cook, citing manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0960-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-04 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook |
| Distribution | FL, KY, MD, NY, PA, TX |
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
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Identifiers
| code_info | Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)…Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0960-2021%22
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