Device recall
Z-0800-2010: HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310…
FDA device recall · Class I · Baxter Healthcare Renal Div
Key facts
| Recall number (Z-number) | Z-0800-2010 |
|---|---|
| Recall event | 54285 |
| Product | HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to… |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Renal Div |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 21, 2017 |
| 510(k) numbers | K053512 |
| FEI number | 3000210122 |
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