Device recall
Z-0932-2015: Baxter Amia Automated PD systems are used in the treatment of adult renal…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0932-2015 |
|---|---|
| Recall event | 69586 |
| Product | Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis. |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2017 |
| 510(k) numbers | K124018 |
| FEI number | 1417572 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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