Device recall
Z-0825-2012: Fresenius Optiflux F250NRe Hemodialyzer,, intended for single use in acute and…
FDA device recall · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-0825-2012 |
|---|---|
| Recall event | 60734 |
| Product | Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog No. 0500325E The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2013 |
| 510(k) numbers | K082414 |
| 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