BEUDAMED
    FDA Enforcement Class II Terminated

    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection

    Recall: Z-2057-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2057-2016
    Event ID
    73584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dynarex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 6, 2016
    Initiation Date
    March 3, 2016
    Classification Date
    June 27, 2016
    Termination Date
    June 6, 2018
    Address
    10 Glenshaw St, Orangeburg, NY, 10962-1207, United States

    Description

    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection

    Reason

    Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.

    Code Info

    Lot Numbers: 31899, 32014, 32015, 32410 & 32411

    Distribution

    US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada

    Quantity

    399 cases/25 sleeves/20 cups & lids per sleeve