FDA-Device2020-12-30Class II

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

Baxter Healthcare Corporation
Hazard

There is a potential software error during programming.

Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Affected count
293,926 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0713-2021

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