CareFusion 303, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1360-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

CareFusion Alaris Pump Module, Model 8100

Product Classification:

Class I

Date Initiated: February 4, 2020

Date Posted: March 11, 2020

Recall Number: Z-1360-2020

Event ID: 84579

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1286898

Code Information:

Software versions 12.1.0, and 9.33 and prior

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated