BEUDAMED
    FDA Enforcement Class II Terminated

    HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.

    Recall: Z-1891-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1891-2013
    Event ID
    65819
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ASO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2013
    Initiation Date
    July 26, 2013
    Classification Date
    August 6, 2013
    Termination Date
    August 4, 2014
    Address
    300 Sarasota Center Blvd, N/A, Sarasota, FL, 34240-9381, United States

    Description

    HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.

    Reason

    This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.

    Code Info

    ASO Packaging Lot #s: 143560, 171871, 250861, 379061, 402860, 418910, 513820, and 544130

    Distribution

    Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.

    Quantity

    Total 2,689,560 pouches (2 cards/pouch)