Recall Z-1767-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1767-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-24

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-04-24. It names one FDA 510(k) clearance: K211122. Product: Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS. Reason: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2025-04-24
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

Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS

Reason for recall

There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

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