Drug recall
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
FDA recall event 96289 · Class I · Baxter Healthcare Corporation
Key facts
| Event ID | 96289 |
|---|---|
| Recall numbers | Z-1253-2025, Z-1254-2025 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX, Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| Initiation date | Feb 5, 2025 |
| Report date | Mar 12, 2025 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: