CareFusion 303, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2826-2020)

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:

Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

Product Classification:

Class II

Date Initiated: June 30, 2020

Date Posted: August 26, 2020

Recall Number: Z-2826-2020

Event ID: 85919

Reason for Recall:

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

Status: Ongoing

Product Quantity: 8558

Code Information:

All serial numbers

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, NJ, TN, NE, WA, KS, MI, MD, WV, KY, UT, MN, IA, GA, AL, DE, AK, VA, OK, NM, CT, SD, NV, ID, MT, ME, VT, MS, WY, NH, MP, DC, ND, GU, PR, AS, RI and the countries of TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, BH.

Voluntary or Mandated:

Voluntary: Firm initiated