Recall – Infusion system errors found following customer changes

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

PRODUCT

Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.

Recall Number: Z-2110-2021

REASON

System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.

RECALLING FIRM/MANUFACTURER

Baxter Healthcare Corporation on 6/4/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

130135 units

DISTRIBUTION

U.S. Nationwide and International

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