BEUDAMED
    FDA Recall Terminated

    Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.

    Recall: Z-1154-06 · Initiated May 15, 2006

    Recall

    Recall Number
    Z-1154-06
    Event Number
    35508
    Firm
    Abbott Spine
    FEI Number
    3000718496
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 15, 2006
    Posted
    June 17, 2006
    Terminated
    September 25, 2007
    Address
    12708 Riata Vista Cir, # B-100, Austin, TX, 78727-7167

    Description

    Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''.

    Reason

    Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.

    Action

    Firm notified sales agents of recall via telephone on 05/15/06 and requested product returns for destruction

    Distribution

    NATIONWIDE-Drapes consigned to sales agents located in CA, FL, IL, MD, MI, OK, OH, TX, and WI.

    Quantity

    326 units.