FDA: Class I recall of Baxter SIGMA Spectrum, Spectrum IQ infusion pumps

Editor's Note

The Food and Drug Administration (FDA), on August 1, identified the recall by Baxter Healthcare Corporation of its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) as Class I, the most serious.

The recall was initiated because of increased reports of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01.

The company reports 131 complaints, 3 serious injuries, and no deaths related to this issue.

Distribution dates were September 29, 2015, to May 2, 2023.