Device recall
Z-1699-2019: 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126…
FDA device recall · Class III · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Recall number (Z-number) | Z-1699-2019 |
|---|---|
| Recall event | 82729 |
| Product | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 30, 2019 |
| 510(k) numbers | K173972 |
| 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