Recall Z-2332-2025— Baxter Healthcare Corporation

Name: FDA recall Z-2332-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-04

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-08-04. It names one FDA 510(k) clearance: K211122. Product: Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump. Reason: 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)..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2025-08-04
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K211122 — Novum IQ Large Volume PumpBaxter Healthcare Corporation·cleared 2024-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, 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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.