Device recall
Z-0105-2011: LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single…
FDA device recall · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-0105-2011 |
|---|---|
| Recall event | 56675 |
| Product | LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico. |
| Product code | FKX |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2023 |
| 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