FDA-Device2020-03-11Class I
CareFusion Alaris PCA Module, Model 8120
CareFusion 303, Inc.
Hazard
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
Sold states
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: Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.
Affected count
83015
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
CareFusion Alaris PCA Module, Model 8120
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1362-2020Don't want to check this manually?
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