Device recall
Z-2082-2013: 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional…
FDA device recall · Class II · Fresenius Medical Care Holdings, Inc. dba Renal Solutions
Key facts
| Recall number (Z-number) | Z-2082-2013 |
|---|---|
| Recall event | 65080 |
| Product | 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where… |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care Holdings, Inc. dba Renal Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2015 |
| 510(k) numbers | K121497 |
| FEI number | 3005778453 |
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