Baxter Healthcare Corporation recalls Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

Recall date

July 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2173-2025

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

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 Novum IQ Large Volume Pump, Product Code REF 40700BAXUS