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Recall Observatory FDA recall evidence

Device product

Novum IQ Syringe infusion system, Product Code 40800BAXUS

Z-0151-2024

October 13, 2023

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 93191
Status
Ongoing
Classification
Class I
Quantity
2023 units
Official record key
device-enforcement:Z-0151-2024

Official wording

Reason: 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.

Code information: All Serial Numbers

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.