Device recall
Z-1278-2018: 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1)…
FDA device recall · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Recall number (Z-number) | Z-1278-2018 |
|---|---|
| Recall event | 79478 |
| Product | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy. |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2021 |
| 510(k) numbers | K153449 |
| 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