FDA-Device2025-01-08Class II

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

Baxter Healthcare Corporation
Hazard

Devices were identified as released after repair without full testing being performed, which includes flow testing.

Sold states
US Nationwide distribution in the states of AL, IN.
Affected count
1 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0775-2025

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