Device recall
Z-0233-2020: Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following…
FDA device recall · Class II · ConvaTec, Inc
Key facts
| Recall number (Z-number) | Z-0233-2020 |
|---|---|
| Recall event | 83993 |
| Product | Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management |
| Product code | EXE |
| Recalling firm | ConvaTec, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2022 |
| 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