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Baxter Healthcare Corp. recalls SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intra
Recalled November 20, 2013 · FDA recall Z-0197-2014 · Baxter Healthcare
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. · FDA Class II
Units
273,835 units
Sold at
Worldwide Distribution-USA including Puerto Rico and Canada.
Description
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.
Product
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →