Baxter has recalled its Novum IQ large volume pump following one serious injury due to under-infusion, the FDA reported. The recall affects over 34,500 units in the U.S. and Canada. The device, used for IV fluids and blood infusion, may deliver up to 50% less than intended after being in standby mode or powered off with a set loaded.
Risks are higher at flow rates above 50 mL/hour and standby times over 2.5 hours. This variability can be harmful, especially for infants. Baxter urges users to monitor patients closely, avoid extended standby use, and remove sets when powering off pumps. Updated instructions and warning posters were issued.
Despite the issue, the Novum IQ platform is still on the market and part of Baxter’s growing U.S. infusion system business, which reported strong Q1 sales growth.
18-06-2025