FDA recall Z-2095-2025
Baxter Healthcare Corporation · Class I · device
Product
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Reason for recall
Certain Spectrum infusion pumps may have an incorrect version of software.
Distribution
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-06-20
- Report date
- 2025-07-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2095-2025