Recall Weekly
Moderate riskFDA DeviceClass II

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

A software problem in the Baxter Novum IQ Syringe Pump (Model 40800BAXUS) can occur when a syringe empties and is replaced during a multi-syringe infusion, potentially affecting the accuracy of medication delivery. The issue affects about 14,601 units distributed nationwide.

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

What to do

  1. Check if you operate or manage this syringe pump model (40800BAXUS).
  2. Contact Baxter Healthcare directly for instructions on software updates or corrective actions.
  3. Do not discard the pump; follow Baxter's guidance for safe continued use or return.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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

This recall covers 2 products — see all of them.

Details

Units affected
14601 units
Illnesses reported
None reported
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Classification
Class II
Recall number
Z-3065-2026

In the FDA's words

Description
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS 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 05413765852428, 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: 14601 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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