Device recall
Z-1314-2008: GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and…
FDA device recall · Class III · ConvaTec
Key facts
| Recall number (Z-number) | Z-1314-2008 |
|---|---|
| Recall event | 47210 |
| Product | GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558. |
| Product code | EXB |
| Recalling firm | ConvaTec |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 21, 2008 |
| FEI number | 3011987967 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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