CareFusion 303, Inc. recalls CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

Recall date

February 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1359-2020

FDA classification

Class I

Brand / firm

CareFusion 303, Inc.

Sold / distributed

Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canad…

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)