FDA-Device2013-11-20Class II
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Baxter Healthcare Corp.
Hazard
Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
Sold states
Worldwide Distribution-USA including Puerto Rico and Canada.
Affected count
273,835 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2014Don't want to check this manually?
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