BEUDAMED
    FDA Recall Terminated

    Sara Active Sling - Standard; item KK53210.0 - model KA1210 (with safety); manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172

    Recall: Z-0426-2007 · Initiated January 9, 2007

    Recall

    Recall Number
    Z-0426-2007
    Event Number
    37085
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 9, 2007
    Posted
    February 15, 2007
    Terminated
    September 2, 2008
    Address
    50 Gary Ave, Ste A, Roselle, IL, 60172-1684

    Description

    Sara Active Sling - Standard; item KK53210.0 - model KA1210 (with safety); manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172

    Reason

    There is the potential for the slings to come apart, potentially allowing injury to the patient.

    Action

    Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/9/07 via FedEx to the end user accounts who received the affected slings, advising them of the potential for the slings to come apart. They were instructed to remove the affected slings from use and replace them with the slings enclosed with the letter, complete the enclosed customer response form, and return the form and the original recalled slings, using the pre-paid call tag provided. If they have any questions or require additional, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140.

    Distribution

    Nationwide

    Quantity

    13 slings