18
Aug
2021

Recall – Infusion pump drug identifier mismatch

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Company: Baxter Healthcare Corporation
Date of Enforcement Report: 8/18/2021
Class I

PRODUCT

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Recall Number: Z-2165-2021

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/MANUFACTURER

Baxter Healthcare Corporation on 7/7/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

61

DISTRIBUTION

U.S. Nationwide

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