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