Device recall
Z-0763-2017: Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for…
FDA device recall · Class II · Oculus Innovative Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-0763-2017 |
|---|---|
| Recall event | 75770 |
| Product | Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses… |
| Product code | FRO |
| Recalling firm | Oculus Innovative Sciences, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 13, 2017 |
| 510(k) numbers | K152055 |
| FEI number | 3004554409 |
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