BEUDAMED
    FDA Recall Terminated

    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

    Recall: Z-0727-2017 · Initiated June 8, 2016

    Recall

    Recall Number
    Z-0727-2017
    Event Number
    74368
    Firm
    Amd-Ritmed, Inc.
    FEI Number
    1319092
    Product Code
    NAC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 8, 2016
    Posted
    December 8, 2016
    Terminated
    February 24, 2017
    Address
    295 Fire Tower Dr, Tonawanda, NY, 14150-5833

    Description

    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

    Reason

    The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.

    Action

    URGENT: MEDICAL DEVICE RECALL Letter (dated 6/8/2016) was e-mailed to the consignees on 6/8/2016. The recall is being conducted to the retail level. For questions. please contact AMD Customer Service by phone at 1-800-445-0340 or by e-mail at [email protected].

    Distribution

    NY, MA, VA, TN

    Quantity

    US: 216 cases (200 dressings per case)