FDA recall Z-2334-2025

Baxter Healthcare Corporation · Class I · device

Product

Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

Distribution

US distribution including Puerto Rico and OUS (International) Canada

Key facts

Status
Ongoing
Initiation date
2025-08-04
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2334-2025