Recall Z-1810-2024— Baxter Healthcare Corporation

Name: FDA recall Z-1810-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-09

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-04-09. It names one FDA 510(k) clearance: K230041. Product: Spectrum IQ Infusion pump, Product Code 357009. Reason: There is a potential for cracks on the mount of the front panel of the device..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-04-09
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K230041 — Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation·cleared 2023-03-31

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

Spectrum IQ Infusion pump, Product Code 357009

Reason for recall

There is a potential for cracks on the mount of the front panel of the device.

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