FDA recall Z-2415-2025

Baxter Healthcare Corporation · Class II · device

Product

Spectrum IQ Infusion Pump, Product Code 3570009

Reason for recall

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

Distribution

US distribution to states of: AZ, FL

Key facts

Status
Ongoing
Initiation date
2025-07-14
Report date
2025-09-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2415-2025