Device recall
Z-0980-2009: Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic…
FDA device recall · Class II · Vance Products Incorporated
Key facts
| Recall number (Z-number) | Z-0980-2009 |
|---|---|
| Recall event | 50223 |
| Product | Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label… |
| Product code | FAD |
| Recalling firm | Vance Products Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2009 |
| 510(k) numbers | K961446 |
| FEI number | 1825146 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database