Device recall
Z-1990-2013: ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For…
FDA device recall · Class III · Convatec Inc.
Key facts
| Recall number (Z-number) | Z-1990-2013 |
|---|---|
| Recall event | 65879 |
| Product | ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. |
| Product code | KNT |
| Recalling firm | Convatec Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 8, 2014 |
| 510(k) numbers | K032734 |
| FEI number | 3011987967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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