Device recall
Z-0801-2025: Dialyzer Optiflux 160NRe
FDA device recall · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-0801-2025 |
|---|---|
| Recall event | 95884 |
| Product | Dialyzer Optiflux 160NRe |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K162488 |
| FEI number | 3001451489 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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