Device recall
Z-0527-2008: Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical…
FDA device recall · Class II · Baxter Healthcare Renal Div
Key facts
| Recall number (Z-number) | Z-0527-2008 |
|---|---|
| Recall event | 45856 |
| Product | Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 |
| Product code | KPF |
| Recalling firm | Baxter Healthcare Renal Div |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2010 |
| 510(k) numbers | K061515 |
| FEI number | 3000210122 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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