Recall archive / FDA device enforcement
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX — FDA record Z-2095-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
- Reason
- Certain Spectrum infusion pumps may have an incorrect version of software.
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 14 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2095-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 23, 2025
- Recall initiation date
- Jun 20, 2025
- Center classification date
- Jul 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.