CareFusion 303, Inc. recalls CareFusion Alaris System, Alaris PC unit models 8000 and 801
Recalled Product
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Hazard / Issue
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Issued by
FDA
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