Device recall
Z-0618-2009: Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1…
FDA device recall · Class II · ConvaTec
Key facts
| Recall number (Z-number) | Z-0618-2009 |
|---|---|
| Recall event | 50225 |
| Product | Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104 ConvaTec Skillman, NJ Made in USA with imported components "For the fecal management of patients with little or no bowel… |
| Product code | KNT |
| Recalling firm | ConvaTec |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2009 |
| 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