Device recall
Z-0291-2016: Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated…
FDA device recall · Class III · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0291-2016 |
|---|---|
| Recall event | 71818 |
| Product | Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 24, 2017 |
| 510(k) numbers | K102936 |
| 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