BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure

    Recall: Z-0464-2014 · Reported December 18, 2013

    Enforcement

    Recall Number
    Z-0464-2014
    Event ID
    66830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 18, 2013
    Initiation Date
    October 28, 2013
    Classification Date
    December 6, 2013
    Termination Date
    January 29, 2014
    Address
    301 Catrell Dr, Howell, MI, 48843-1703, United States

    Description

    Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure

    Reason

    Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies.

    Code Info

    EB84, Lot 2013041801 Expriation 2018/03

    Distribution

    US Distribution including the states of GA, LA and NY.

    Quantity

    500 lots