FDA recall Z-0123-2021

Product

Spectrum IQ Infusion System with Dose IQ Safety Software

Reason for recall

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

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)

Key facts

Status

Terminated

Initiation date

2020-06-30

Report date

2020-10-28

Termination date

2024-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

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