BEUDAMED
    FDA Enforcement Class I Ongoing

    Alaris PCA Module 8120

    Recall: Z-0186-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0186-2024
    Event ID
    93106
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    November 15, 2023
    Initiation Date
    September 15, 2023
    Classification Date
    November 6, 2023
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Alaris PCA Module 8120

    Reason

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

    Code Info

    All Lots/ UDI-DI: 10885403516023,10885403515231,10885403801549,10885403515248, 10885403801532,10885403515224,10885403801518

    Distribution

    Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; OUS (foreign): Canada, Germany, Cuba, Italy, Japan, South Korea, Turkey, United Arab Emirates, Australia, Bahrain, Botswana, Kuwait, Mexico, Netherlands, Philippines, Pakistan, Qatar, South Africa, Singapore, Belgium, Israel, India, New Zealand, Malaysia, Taiwan, Switzerland

    Quantity

    86,393 units