BEUDAMED
    FDA Enforcement Class II Terminated

    SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.

    Recall: Z-0004-2014 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-0004-2014
    Event ID
    66357
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ASO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 9, 2013
    Initiation Date
    August 21, 2013
    Classification Date
    October 1, 2013
    Termination Date
    August 4, 2014
    Address
    300 Sarasota Center Blvd, Sarasota, FL, 34240-9381, United States

    Description

    SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.

    Reason

    No antibacterial bandages were packed in boxes labeled as antibacterial.

    Code Info

    UPC Code #: 400129133311 Lot numbers: 330543 and 341383

    Distribution

    Distributed in the states of ID, WI, IN, and NE.

    Quantity

    37 cases (72 retail boxes in each case)