Device recall
Z-0173-2012: Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter…
FDA device recall · Class II · Baxter Healthcare Renal Div
Key facts
| Recall number (Z-number) | Z-0173-2012 |
|---|---|
| Recall event | 60183 |
| Product | Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis |
| Product code | KDI |
| Recalling firm | Baxter Healthcare Renal Div |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2011 |
| 510(k) numbers | K970446 |
| 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