Recall Z-1423-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1423-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-03

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-03-03. It names one FDA 510(k) clearance: K242390. Product: Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS. Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-03-03
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K242390 — Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation·cleared 2024-09-05

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 NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

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