Device recall
Z-1292-2015: The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-1292-2015 |
|---|---|
| Recall event | 66737 |
| Product | The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2017 |
| 510(k) numbers | K102936 |
| FEI number | 1416980 |
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