Z-0960-2021 Class II Terminated
FDA device recall Z-0960-2021 was initiated by Cook Inc. on Jan 4, 2021 and is designated Class II. 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. The recall status is terminated (terminated Sep 16, 2021). Affected quantity: 42 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 17, 2021
- Initiation Date
- Jan 4, 2021
- Termination Date
- Sep 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
Product Description
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.
Distribution Pattern
FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
Code Information
Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0960-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026