Agency classClass IOur severity:Critical FDA (Devices)·Z-2173-2025·Announced 2025-08-20

Infusion pumps recalled over underinfusion when flow rate more than doubles

Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I action, and the FDA classified this infusion pump correction as Class I.

Plain-English summary

The Baxter Novum IQ Large Volume Pump, product code REF 40700BAXUS, UDI-DI 05413765851797, is the subject of an Urgent Medical Device Correction covering all serial numbers. The action covers 36,705 units distributed in the United States and Canada.

Baxter issued the correction because of the potential for underinfusion when the pump transitions from one flow rate to a higher flow rate that is more than double the current rate, for example on a rate change or bolus. The level of underinfusion varies with the current infusion rate, how long the pump has been running at that rate, and the size of the rate change: the longer the pump has run at the current rate and the larger the change, the larger the underinfusion. Baxter has also identified an increase in customer reports of over- and underinfusion potentially caused by set misloading, where tubing that is not properly loaded into the pump channel may cause the pump to infuse above or below the programmed rate. The FDA classified the action as Class I, its most serious category.

Baxter instructs customers, consistent with the instructions for use, to ensure that the door is fully open before loading the set and that the tubing is taut and loaded without slack in the pumping channel. Hospitals operating these pumps should follow Baxter's correction notice in full.

The recalled product

Product: Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: underinfusion
dosing-error
set-misloading
infusion-pump
class-i
Affected units: 36,705

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI/DI 05413765851797
All Serial Numbers

Distribution

Distributed nationwide across the United States.

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · underinfusion