Baxter Healthcare Corporation: Novum IQ Syringe Infusion System Recalled for Alarm and Fluid Delivery Errors

Agency Publication Date: November 9, 2023

Summary

Baxter Healthcare Corporation is recalling 2,023 units of the Novum IQ Syringe infusion system (Product Code 40800BAXUS) because the device may fail to deliver the full amount of medication. After multiple blockage alarms, the pump may incorrectly signal that an infusion is complete even when uninfused fluid remains in the syringe. This issue affects all serial numbers of the Novum IQ Syringe Pump across the United States.

Risk

If the pump falsely indicates an infusion is complete, patients may receive less medication than prescribed. This failure to deliver the intended dose can lead to serious health complications or a delay in critical treatment.

What You Should Do

Identify if you have the Novum IQ Syringe infusion system by checking for Product Code 40800BAXUS on the device labeling.
Be aware that this recall affects all serial numbers of the Novum IQ Syringe Pump.
If you are using this device, pay close attention to downstream occlusion (blockage) alarms and verify that the syringe is empty when an 'Infusion Complete' alarm sounds.
Contact your healthcare provider or Baxter Healthcare Corporation at 1-888-463-6332 for further instructions regarding the correction of these devices and any necessary service.
Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.
For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Urgent Medical Device Correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Novum IQ Syringe infusion system

Model / REF:

40800BAXUS

Lot Numbers:

All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93191

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 2023 units

Distributed To: Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

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

Identify if you have the Novum IQ Syringe infusion system by checking for Product Code 40800BAXUS on the device labeling.

Be aware that this recall affects all serial numbers of the Novum IQ Syringe Pump.

If you are using this device, pay close attention to downstream occlusion (blockage) alarms and verify that the syringe is empty when an 'Infusion Complete' alarm sounds.

Contact your healthcare provider or Baxter Healthcare Corporation at 1-888-463-6332 for further instructions regarding the correction of these devices and any necessary service.

Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.

For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.