Device recall
Z-0495-2020: MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
FDA device recall · Class II · AMD Medicom Inc.
Key facts
| Recall number (Z-number) | Z-0495-2020 |
|---|---|
| Recall event | 84118 |
| Product | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 |
| Product code | FXX |
| Recalling firm | AMD Medicom Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2021 |
| 510(k) numbers | K051291 |
| FEI number | 3002677549 |
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