Device recall
Z-2249-2016: Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
FDA device recall · Class II · Amerx Health Care Corp.
Key facts
| Recall number (Z-number) | Z-2249-2016 |
|---|---|
| Recall event | 74249 |
| Product | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. |
| Product code | KMJ |
| Recalling firm | Amerx Health Care Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2016 |
| 510(k) numbers | K970133 |
| FEI number | 1000525408 |
At a glance
- 1–9 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