BEUDAMED
    FDA Recall Terminated

    Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.

    Recall: Z-2094-2009 · Initiated July 13, 2009

    Recall

    Recall Number
    Z-2094-2009
    Event Number
    52683
    Firm
    Integra Life Sciences Corporation
    FEI Number
    1000138491
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 13, 2009
    Posted
    September 21, 2009
    Terminated
    October 23, 2009
    Address
    3395 W 1820 S, Salt Lake City, UT, 84104-4921

    Description

    Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.

    Reason

    Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.

    Action

    Consignees were notified by telephone on July 09, 2009 and by "Urgent Medical Device Recall" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.

    Distribution

    Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.

    Quantity

    30 units