Recall Z-2165-2021— Baxter Healthcare Corporation

Name: FDA recall Z-2165-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-07

Class I · Terminated

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-07-07, terminated 2024-06-20. It names one FDA 510(k) clearance: K173084. Product: Dose IQ Safety Software used with Spectrum IQ Infusion Pump. Reason: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Terminated
Initiated: 2021-07-07
Terminated: 2024-06-20
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K173084 — Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation·cleared 2018-05-11

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

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Reason for recall

Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.

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