PlainRecalls
FDA Devices Critical Class I Terminated

Spectrum IQ Infusion System with Dose IQ Safety Software

Reported: October 28, 2020 Initiated: June 30, 2020 #Z-0123-2021

Product Description

Spectrum IQ Infusion System with Dose IQ Safety Software

Reason for Recall

Baxter is updating the device IFU for safety communication regarding cleaning practices.

Details

Units Affected
146,224 units
Distribution
Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Spectrum IQ Infusion System with Dose IQ Safety Software. Recalled by Baxter Healthcare Corporation. Units affected: 146,224 units.
Why was this product recalled?
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 28, 2020. Severity: Critical. Recall number: Z-0123-2021.