Device recall
Z-0738-2008: Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius…
FDA device recall · Class II · Fresenius Medical Care North America
Key facts
| Recall number (Z-number) | Z-0738-2008 |
|---|---|
| Recall event | 46292 |
| Product | Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer) |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2008 |
| 510(k) numbers | K002277 |
| 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