BEUDAMED
    FDA Recall 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 · Initiated June 2, 2021

    Recall

    Recall Number
    Z-2081-2021
    Event Number
    88122
    Firm
    Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
    FEI Number
    3004386693
    Product Code
    QMT
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 2, 2021
    Terminated
    April 28, 2022

    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.

    Action

    McKesson issued an "URGENT MEDICAL DEVICE SAFETY ALERT" on 06/02/2021 by email to its consignees. The notice requested that the consignees do the following: -examine their inventory immediately to determine if you have any quantities of the product, -Immediately stop using these syringes with 3mI syringes with conventional needles for the administration of the Moderna COVID-19 vaccine. -As these 3mI syringes with conventional needles can be utilized for a variety of other uses, such as medication mixing in healthcare settings, you may continue to use these 3mI syringes with conventional needles in your healthcare facility for other appropriate uses. -Please fill out and return the Medical Device Alert Response Form attached. The firm would be shipping replacement safety syringes. For questions about this notification, please call 877-546-5661.

    Distribution

    US Nationwide Distribution

    Quantity

    53,388 kits