Device recall
Z-0138-2015: Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400…
FDA device recall · Class III · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-0138-2015 |
|---|---|
| Recall event | 69279 |
| Product | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process… |
| Product code | NAD |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 21, 2015 |
| FEI number | 2125050 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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