Medical device recalls High risk

Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Recall date
February 5, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1254-2025
FDA classification
Class I
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US: Nationwide

Why it was recalled

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

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 Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

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