FDA recall Z-1253-2025

Baxter Healthcare Corporation · Class I · device

Product

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

Reason for recall

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

Distribution

US: Nationwide

Key facts

Status
Ongoing
Initiation date
2025-02-05
Report date
2025-03-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2025