Recall Z-1775-2024— Baxter Healthcare Corporation

Name: FDA recall Z-1775-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-20

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-03-20. It names one FDA 510(k) clearance: K230041. Product: Baxter Spectrum IQ Infusion Pump, Product Code 3570009. Reason: One device was improperly performed testing prior to release from a Service Center..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-03-20
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

Baxter Spectrum IQ Infusion Pump, Product Code 3570009

Reason for recall

One device was improperly performed testing prior to release from a Service Center.

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