Device recall
Z-0455-2007: HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7''…
FDA device recall · Class II · Embeem Inc.
Key facts
| Recall number (Z-number) | Z-0455-2007 |
|---|---|
| Recall event | 36831 |
| Product | HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch. |
| Product code | NAE |
| Recalling firm | Embeem Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2008 |
| FEI number | 3005089721 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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