FDA warns – Novum IQ Syringe Pump recalled by Baxter Healthcare Corporation due to risk of under-dose

According to the FDA, Baxter Healthcare Corporation’s September 21, 2023 recall of its Novum IQ Syringe Pump is now identified as Class I, the most serious type, because use of the device has been found to put users at risk of serious injuries or death.

An infusion pump indicated to deliver a precise and controlled amount of fluids (nutrients or medications) into a patient’s body, the Novum IQ syringe pump is designed to be administered by trained healthcare professionals. It is used in both hospital and outpatient healthcare settings on adult and pediatric patients, as well as neonates.

Baxter Healthcare Corporation initiated the recall on September 21, 2023 after officials found that a software error could potentially miscalculate volume after the Novum IQ Syringe Infusion Pump detects a blockage, or inclusion. The error may then cause the pump to indicate an infusion is complete even when it is not.

The product defect poses a risk of major adverse health outcomes and death, especially to patients who rely on the delivery of a precise amount of life-sustaining medications or other fluids in a time-sensitive manner.

In an Urgent Medical Device Correction letter sent on October 13, 2023, Baxter Healthcare Corporation outlined a series of recommendations for patients who receive an infusion via the Novum Syringe Infusion System in a clinical setting and the healthcare providers who administer the infusion therapy:

  • After an infusion as been completed, monitor the remaining fluid in the syringe. Take note when one or several downstream blockages have alarmed.
    • In the event that the total dose is not delivered even after the “Infusion Complete” alarm, the pump should be re-programed and the remaining volume should be delivered as necessary.
  • Expect your facility to be contacted by a Baxter representative when a software upgrade for the device is made available.
  • Read and acknowledge receipt of the correction letter by submitting a response on the Baxter customer portal via https://BaxterFieldActionCustomerPortal.onprocess.com, even if no inventory remains.

U.S. customers may direct any recall-related questions and concerns to Baxter Global Technical Services at 800-843-7867. Representatives are available Monday through Friday, from 7:00 a.m. to 7:00 p.m. Eastern Time.

As the FDA continues to monitor this recall, healthcare professionals and consumers are encouraged to report any related adverse reactions or quality issues to the agency’s MedWatch program.


If you have suffered an adverse health outcome that can be traced to a medical device defect or mis-use of a device in a clinical setting, you deserve a compassionate legal advocate and maximum compensation. Our experienced attorneys at TruLaw are personally invested in protecting consumer safety standards and holding negligent parties responsible. To learn about how we can support you, connect with us online or try out our free Instant Case Evaluation ℠ .