BEUDAMED
    FDA Recall 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 · Initiated March 3, 2016

    Recall

    Recall Number
    Z-2057-2016
    Event Number
    73584
    Firm
    Dynarex Corporation
    FEI Number
    2431014
    Product Code
    NNI
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 3, 2016
    Terminated
    June 6, 2018
    Address
    10 Glenshaw St, Orangeburg, NY, 10962-1207

    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.

    Action

    On March 2, 2016, dynarex Corporate Headquarters distributed Voluntary Device Recall notices and Recall Verification Forms to their customers via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to examine their stock immediately to determine if they have any of the lots listed on hand. If so, discontinue distributing and quarantine the product immediately. Promptly contact the Dynarex Credit & Return representative Avi Celnick (845-365-8200 Ext 6644) to arrange for product return. Customers account will be credited for all returned products. All customers are advised to complete the Voluntary Recall Verification Form and returm immediately via fax or e-mail to Vijay Sachdev (Fax 845-365-8238; [email protected]).

    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