Device recall
Z-0525-2018: SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible…
FDA device recall · Class II · ConvaTec, Inc
Key facts
| Recall number (Z-number) | Z-0525-2018 |
|---|---|
| Recall event | 78507 |
| Product | SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin. |
| Product code | PQE |
| Recalling firm | ConvaTec, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2023 |
| 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