Device recall
Z-3194-2018: 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T…
FDA device recall · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Recall number (Z-number) | Z-3194-2018 |
|---|---|
| Recall event | 80875 |
| Product | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated 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 17, 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