BEUDAMED
    FDA Enforcement Class II Terminated

    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine

    Recall: Z-2081-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2081-2021
    Event ID
    88122
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mckesson Medical-Surgical Inc. Corporate Office
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 28, 2021
    Initiation Date
    June 2, 2021
    Classification Date
    July 16, 2021
    Termination Date
    April 28, 2022
    Address
    9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States

    Description

    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine

    Reason

    Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.

    Code Info

    All convenience kit lot numbers distributed 5/4/2021 - 5/24/2021, containing syringes as follows: a) SYRINGE/NDL, 3CC 25GX1 1/2" BD, Lot numbers: 9252960, 0296288, 9252961 b) SYRINGE/NDL, 3CC 23GX1 1/2" BD, Lot Numbers: 0324763, 0324761, 0324766, 0324770, 1015383, 1020431

    Distribution

    US Nationwide Distribution

    Quantity

    53,388 kits