FDA-Device2023-11-15Class I

Novum IQ Syringe infusion system, Product Code 40800BAXUS

Baxter Healthcare Corporation
Hazard

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.

Sold states
US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Affected count
2023 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Novum IQ Syringe infusion system, Product Code 40800BAXUS

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0151-2024

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