FDA-Device2020-10-28Class I
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
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
310,969 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2021Don't want to check this manually?
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