Company: CareFusion 303, Inc.
Date of Enforcement Report: 3/11/2020
Class I
PRODUCT
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
- Recall Number: Z-1359-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc. on 2/4/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
870070
DISTRIBUTION
US Nationwide and International