Device recall
Z-2731-2017: Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s)…
FDA device recall · Class II · O-Two Medical Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-2731-2017 |
|---|---|
| Recall event | 77534 |
| Product | Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns. |
| Product code | NAE |
| Recalling firm | O-Two Medical Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2017 |
| FEI number | 3002807836 |
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