Device recall
Z-0184-2014: 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog…
FDA device recall · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-0184-2014 |
|---|---|
| Recall event | 65739 |
| Product | 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. |
| Product code | ONW |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2021 |
| 510(k) numbers | K070049 |
| FEI number | 3001451489 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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