FDA recall Z-0775-2025

Baxter Healthcare Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of AL, IN.

Key facts

Status
Ongoing
Initiation date
2024-11-19
Report date
2025-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

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