BEUDAMED
    FDA Enforcement Class II Completed

    Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037

    Recall: Z-2038-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2038-2019
    Event ID
    82927
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    April 30, 2019
    Classification Date
    July 23, 2019
    Address
    15 Hampshire St Bldg 5, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037

    Reason

    Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

    Code Info

    Lot Number:904212, 905612, 907002

    Distribution

    Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL

    Quantity

    N/A