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Recall Observatory FDA recall evidence

Device product

Alaris PCA Module Model 8120 - 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.

Z-2824-2020

June 30, 2020

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 85919
Status
Ongoing
Classification
Class II
Quantity
89497
Official record key
device-enforcement:Z-2824-2020

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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