BEUDAMED
    FDA Enforcement Class II 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 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0727-2017
    Event ID
    74368
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amd-Ritmed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 14, 2016
    Initiation Date
    June 8, 2016
    Classification Date
    December 8, 2016
    Termination Date
    February 24, 2017
    Address
    295 Fire Tower Dr, N/A, Tonawanda, NY, 14150-5833, United States

    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.

    Code Info

    Lot 68408, expiration date 2018¿05

    Distribution

    NY, MA, VA, TN

    Quantity

    US: 216 cases (200 dressings per case)