The FDA labeled 22,769 Baxter drug infusion devices as a Class I recall after receiving reports of false upstream occlusion alarms, which can delay therapy.
The two infusion pumps, SIGMA Spectrum Infusion Pump with Master Drug Library and Spectrum IQ Infusion System with Dose IQ Safety Software, deliver pharmaceuticals, blood and blood products, and other therapies.
Interrupted regimens can lead to serious adverse events, the FDA said Aug. 1. Baxter has reported 131 complaints, three serious injuries and zero deaths.
The medical device company notified its customers in mid-June and said it would "contact facilities to determine the correction plan and schedule a no charge software reversion for all affected pumps to the previous software version," according to the FDA.