medical Class I Updated 2020-03-11

CareFusion 303, Inc. recalls CareFusion Alaris PCA Module, Model 8120

Recalled Product

CareFusion Alaris PCA Module, Model 8120


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

Distribution: Nationwide (United States)
Lot/Code Info: Software versions 12.1.0, and 9.33 and prior
View official government recall

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