RecallDepth

Novum IQ Syringe infusion system, Product Code 40800BAXUS

This recall is currently active, issued November 9, 2023. It was issued by Baxter Healthcare Corporation.

Company
Baxter Healthcare Corporation
Recall Initiated
October 13, 2023
Posted
November 9, 2023
Recall Number
Z-0151-2024
Quantity
2023 units
Firm Location
Deerfield, IL
Official Source
View on FDA website ↗

Reason for Recall

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.

Distribution

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.

Lot / Code Info

All Serial Numbers

Root Cause

Under Investigation by firm

Action Taken

Baxter issued an "Urgent Medical Device Correction" notice on 10/13/2023 via USPS first-class mail. The notice explained the issue, hazard involved, and provided mitigation procedures in accordance with the Operator's Manual until a software upgrade becomes available. For additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867, Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.

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