Device recall
Z-1059-2023: FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops…
FDA device recall · Class III · Owens & Minor Distribution, Inc.
Key facts
| Recall number (Z-number) | Z-1059-2023 |
|---|---|
| Recall event | 91530 |
| Product | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147 |
| Product code | FXX |
| Recalling firm | Owens & Minor Distribution, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K131879 |
| FEI number | 3003753847 |
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