FDA-Device2014-04-30Class I
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
Baxter Healthcare Corp.
Hazard
Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
Sold states
Worldwide Distribution - USA Nationwide including PR and the country of Canada.
Affected count
277,096 units (revised)
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2014Don't want to check this manually?
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