BEUDAMED
    FDA Recall Open, Classified

    BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

    Recall: Z-2882-2020 · Initiated August 4, 2020

    Recall

    Recall Number
    Z-2882-2020
    Event Number
    86005
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    August 4, 2020
    Posted
    September 4, 2020
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

    Reason

    The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

    Action

    The recall letter was sent via FedEx, 2nd day air, on August 4, 2020. On December 16, 2022, CareFusion expanded the recall to include additional affected customers. The notification was mailed via FedEx, 2nd day Air. Action for Clinical Users: Ensure that the displayed syringe manufacturer and syringe size correctly identify the installed syringe. If the PC unit displays an incorrect syringe type and/or size, remove the device from service and send to Biomedical Engineering for repair. The biomedical engineer should: - Conduct a barrel clamp accuracy test as outlined in the "Preventive Maintenance" section of the BD Alaris" System Maintenance - Software User Manual and replace syringe barrel clamp mechanism if required. - Contact BD at 1-800-482-4822 to order a Syringe/PCA Sizer Sensor Replacement Kit at no charge, or - Contact the BD Recall Support Center at 888-562-6018 to send the module to the BD Service Depot for repair at no charge. Actions by BD: BD is redesigning the syringe barrel clamp mechanism as a quality improvement.

    Distribution

    US - AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY OUS - AE, AU, BE, BH, CA, CH, CN, IN, KW, MX, MY, NL, NZ, PH, QA, SA, TW and ZA

    Quantity

    180,186 parts & devices