Device recall
Z-1448-2012: Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and…
FDA device recall · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-1448-2012 |
|---|---|
| Recall event | 60865 |
| Product | Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis. |
| Product code | FKX |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2016 |
| 510(k) numbers | K043363 |
| FEI number | 3001451489 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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