Medical device recalls High risk

Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

Recall date
June 20, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2096-2025
FDA classification
Class I
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

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