BEUDAMED
    FDA Recall Terminated

    Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.

    Recall: Z-1896-2013 · Initiated July 26, 2013

    Recall

    Recall Number
    Z-1896-2013
    Event Number
    65819
    Firm
    ASO, LLC
    FEI Number
    1038758
    Product Code
    MGO
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 26, 2013
    Posted
    August 6, 2013
    Terminated
    August 4, 2014
    Address
    300 Sarasota Center Blvd, Sarasota, FL, 34240-9381

    Description

    Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 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.

    Action

    ASO sent a letter on July 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine your inventory and stop using/distributing the product. Place in quarantine to be returned or destroyed. ASO customers will receive credit for returned product or a returned completed Certificate of Destruction. Please use Return Authorization Number 1675 when returning the product. Please complete and return the enclosed response form as soon as possible. Return the form to: Address: ASO LLC Regulatory Affairs 300 Sarasota Center Blvd. Sarasota, FL 34240 Fax: 941-378-9040 Attn: Regulatory Affairs For questions regarding this recall call 888-364-7004, ext 146.

    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)