Reported Jan 28, 2026 · Ongoing
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- SIGMA Spectrum Infusion Pump
- Model/Catalog Number35700BAX2
- Lot codes and dates
- GTIN 00085412498683
- Serial Numbers
585 of 585 codes
211905421357352132190215466621546562096922210788221158202116236212375021244672142165214569321465702135601215015920196142030571206447420658752007842207707721100002139163215238720900112150576200674120908772091360211560521367562145367214591121443662147107200581820364442040404206448820543172064576206538020647112055127206648620658522065982204195520810262023286208810620899082089953209001220962712106362211476021142752116368
- Amount recalled
- 585 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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