Device recall
Z-0852-2011: Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF…
FDA device recall · Class II · Vance Products Incorporated
Key facts
| Recall number (Z-number) | Z-0852-2011 |
|---|---|
| Recall event | 57352 |
| Product | Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder. |
| Product code | FAD |
| Recalling firm | Vance Products Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2011 |
| 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