Baxter Novum IQ Large Volume Pumps Recalled for Infusion Errors

Agency Publication Date: August 14, 2025

Summary

Baxter Healthcare Corporation is recalling approximately 36,705 Novum IQ Large Volume Pumps (Product Code REF 40700BAXUS) because the devices may underinfuse medication when transitioning to a flow rate that is more than double the previous rate, such as during a bolus. Additionally, the company has identified reports of both over- and underinfusion caused by improper tubing installation (set misloading). These errors can lead to patients receiving the incorrect dosage of medication.

Risk

Failure to deliver the programmed amount of medication can result in inadequate treatment or overdose, potentially leading to serious health complications. Baxter has received customer reports of delivery errors specifically related to how the tubing is loaded into the pump channel.

What You Should Do

This recall involves the Baxter Novum IQ Large Volume Pump, identifiable by Product Code REF 40700BAXUS and UDI/DI 05413765851797. All serial numbers for this model are affected.
Check your device for the Product Code REF 40700BAXUS and the UDI/DI 05413765851797 printed on the product labeling. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
If continuing to use the device during the transition period, ensure the pump door is fully open before loading the set and verify the tubing is taut and loaded without any slack in the pumping channel.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

Urgent Medical Device Correction/Return/Replacement

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baxter Novum IQ Large Volume Pump

Model / REF:

40700BAXUS

Serial Numbers:

All Serial Numbers

UDI:

05413765851797

Recall #: Z-2173-2025; Urgent Medical Device Correction issued due to underinfusion and set misloading risks.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97164

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospital supply distributors; Direct sales to healthcare facilities

Manufactured In: United States

Units Affected: 36705 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the Baxter Novum IQ Large Volume Pump, identifiable by Product Code REF 40700BAXUS and UDI/DI 05413765851797. All serial numbers for this model are affected.

Check your device for the Product Code REF 40700BAXUS and the UDI/DI 05413765851797 printed on the product labeling. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

If continuing to use the device during the transition period, ensure the pump door is fully open before loading the set and verify the tubing is taut and loaded without any slack in the pumping channel.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.