Device recall
Z-0179-2010: System 1000 family of Hemodialysis Instruments, including the System 1000, TINA…
FDA device recall · Class II · Baxter Healthcare Renal Div
Key facts
| Recall number (Z-number) | Z-0179-2010 |
|---|---|
| Recall event | 53139 |
| Product | System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux… |
| Product code | KDI |
| Recalling firm | Baxter Healthcare Renal Div |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2010 |
| 510(k) numbers | K013562, K954987 |
| FEI number | 3000210122 |
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