Device recall
Z-0939-2015: HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0939-2015 |
|---|---|
| Recall event | 69468 |
| Product | HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and… |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2016 |
| 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