FDA-Device2020-10-28Class I

Spectrum IQ Infusion System with Dose IQ Safety Software

Baxter Healthcare Corporation
Hazard

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

Sold states
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)
Affected count
146,224 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Spectrum IQ Infusion System with Dose IQ Safety Software

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2021

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