Device recall
Z-1253-2025: Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
FDA device recall · Class I · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-1253-2025 |
|---|---|
| Recall event | 96289 |
| Product | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K133801 |
| FEI number | 1417572 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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