PlainRecalls
FDA Devices Critical Class I Ongoing

Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

Reported: July 23, 2025 Initiated: June 20, 2025 #Z-2096-2025

Product Description

Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

Reason for Recall

Certain Spectrum infusion pumps may have an incorrect version of software.

Details

Units Affected
28 units
Distribution
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2. Recalled by Baxter Healthcare Corporation. Units affected: 28 units.
Why was this product recalled?
Certain Spectrum infusion pumps may have an incorrect version of software.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 23, 2025. Severity: Critical. Recall number: Z-2096-2025.