Catheter, Ureteral, General & Plastic Surgery
FDA product code GBL · Not classified · 21 CFR 876.5130 · Gastroenterology, Urology
0510(k) clearances
0PMA approvals
2recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0972-2020 Class II | Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-2617-2016 Class II | Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | Cook Inc. | 04/15/2016Terminated |