Device recall
Z-0565-03: HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter…
FDA device recall · Class III · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0565-03 |
|---|---|
| Recall event | 25284 |
| Product | HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 11, 2007 |
| 510(k) numbers | K012988 |
| 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