Device recall
Z-1951-2010: Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius…
FDA device recall · Class II · Fresenius Medical Care North America
Key facts
| Recall number (Z-number) | Z-1951-2010 |
|---|---|
| Recall event | 55771 |
| Product | Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis. |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2011 |
| 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