Device recall
Z-1516-2015: Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or…
FDA device recall · Class II · PhotoMedex, Inc.
Key facts
| Recall number (Z-number) | Z-1516-2015 |
|---|---|
| Recall event | 70838 |
| Product | Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination. |
| Product code | MGQ |
| Recalling firm | PhotoMedex, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2015 |
| 510(k) numbers | K953853, K964468 |
| FEI number | 3000206133 |
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