FDA-Device2026-01-28Class II
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Baxter Healthcare Corporation
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
585 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1121-2026Don't want to check this manually?
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