Device recall
Z-0189-05: HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured…
FDA device recall · Class II · Baxter Healthcare Renal Div
Key facts
| Recall number (Z-number) | Z-0189-05 |
|---|---|
| Recall event | 30274 |
| Product | HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Renal Div |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2007 |
| 510(k) numbers | K012988 |
| 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