FDA-Device2026-09-09Class IIPROCESSING DEFECT
Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
What this means
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.
- If you operate this pump model, contact Baxter Healthcare Corporation for guidance or replacement.
- Do not use the pump if you have concerns about its operation during syringe changes.
- Report any adverse events to the FDA MedWatch program.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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 count
4 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3066-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
- FDA-Drug2026-09-09Baxter Vasopressin injection recalled for manufacturing quality deviations
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