Device recall
Z-1993-2014: Amerigel Wound Dressing 55 gallons/drum
FDA device recall · Class II · Kova Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1993-2014 |
|---|---|
| Recall event | 68488 |
| Product | Amerigel Wound Dressing 55 gallons/drum |
| Product code | MGQ |
| Recalling firm | Kova Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 12, 2016 |
| 510(k) numbers | K971918 |
| FEI number | 3005050034 |
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