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