Device recall
Z-0333-06: Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number…
FDA device recall · Class III · Fresenius Medical Care North America
Key facts
| Recall number (Z-number) | Z-0333-06 |
|---|---|
| Recall event | 34165 |
| Product | Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care North America |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 10, 2006 |
| 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