Device recall
Z-0001-05: Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25…
FDA device recall · Class II · DeRoyal Wound Care
Key facts
| Recall number (Z-number) | Z-0001-05 |
|---|---|
| Recall event | 29815 |
| Product | Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA*** |
| Product code | MGQ |
| Recalling firm | DeRoyal Wound Care |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2004 |
| FEI number | 1000123222 |
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