Recall Z-0960-2021 ยท FAD Stent, Ureteral
Cook Inc.
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
| Date | Jan 4, 2021 |
| Status | Terminated |
| Reason | Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation. |
| Root cause | Nonconforming Material/Component |
| Action | Cook issued Urgent Medical Device Recall Letter on Jan 4 , 2021 via email/mail. Letter states reason for recall, health risk and action to take: If affected products are currently indwelling in a patient, consider scheduling a follow-up with the patient to remove and/or replace the product, based on the status and preferences of each individual patient. 2.Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 3.Return the affected product(s) to Cook Medical w |
| Quantity | 42 units |
| Distribution | FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162109 | Kwart Retro-Inject Ureteral Stent Cook Incorporated, Jun 7, 2017 |