Device recall
Z-0841-06: Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for…
FDA device recall · Class II · Southwest Technologies Inc
Key facts
| Recall number (Z-number) | Z-0841-06 |
|---|---|
| Recall event | 35051 |
| Product | Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by… |
| Product code | FRO |
| Recalling firm | Southwest Technologies Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2007 |
| 510(k) numbers | K872165 |
| FEI number | 1929833 |
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