Recall Weekly
Moderate riskFDA DeviceClass II

Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion

A software issue in the Baxter Novum IQ Syringe Pump (Model 40800BAXUSL) may occur when you replace an empty syringe during a multi-syringe infusion while medication still needs to be delivered. This could affect the accuracy of drug delivery. Four loaner units have been identified and are affected.

From the FDA notice · Read the official notice ↗ · All Baxter recalls

What to do

  1. If you operate this pump model, contact Baxter Healthcare Corporation for guidance or replacement.
  2. Do not use the pump if you have concerns about its operation during syringe changes.
  3. Report any adverse events to the FDA MedWatch program.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Sold in
Nationwide
Made for
Adults

This recall covers 2 products — see all of them.

Details

Units affected
4 units
Illnesses reported
None reported
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Classification
Class II
Recall number
Z-3066-2026

In the FDA's words

Description
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. UDI-DI 00197886002300, all serial numbers Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Affected quantity: 4 units
Hazard
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

2 products in this recall

Baxter Novum IQ syringe pumps recalled for software issue

Baxter is recalling two Novum IQ syringe pump models, totaling about 14,605 units. During a Volume/Time (VOT) multi-syringe infusion, a software issue may occur if a syringe runs empty and is replaced while the Volume To Be Infused (VTBI) is still remaining. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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