FDA recall Z-1121-2026

Baxter Healthcare Corporation · Class II · device

Product

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

Reason for recall

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-11-28
Report date
2026-01-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1121-2026