BEUDAMED
    FDA Recall Terminated

    Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for Medline Industries, Mundelein IL 60060

    Recall: Z-2198-2011 · Initiated February 22, 2011

    Recall

    Recall Number
    Z-2198-2011
    Event Number
    58198
    Firm
    Jiangsu Wujin Hualian Health Dressing Co., Ltd.
    FEI Number
    3003807757
    Product Code
    KGX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 22, 2011
    Posted
    May 13, 2011
    Terminated
    April 23, 2012
    Address
    55 Yuejin Rd., Zouqu Town Wujin City, Jiangsu Prov. China

    Description

    Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for Medline Industries, Mundelein IL 60060

    Reason

    The sterility of the product has the potential to be compromised due to weak sealing of the bandages.

    Action

    Changzhou Hualian Health Dressing Co., Ltd notified sole consignee by e-mail and a Medical Device Recall letter, dated 3/18/2011. The letter identifies the affected product and the reason for the recall. The customer was to examine their inventory and quarantine the affected product. If the product had been further distributed, those customers were to be identified and notified of the recall. The enclosed response form was to be completed and returned to Medline Industries, Inc. Questions could be directed to Customer Service, Monday through Friday between 8:30 A.M. and 4:00 P.M.

    Distribution

    Nationwide Distribution -- IL.

    Quantity

    1,092 cases