BEUDAMED
    FDA Recall Terminated

    ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.

    Recall: Z-2196-2010 · Initiated June 23, 2010

    Recall

    Recall Number
    Z-2196-2010
    Event Number
    56157
    Firm
    Ascent Healthcare Solutions, Inc.
    FEI Number
    1000132435
    Product Code
    NMF
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    June 23, 2010
    Posted
    August 10, 2010
    Terminated
    August 11, 2010
    Address
    5307 Great Oak Drive, Lakeland, FL, 33815-3113

    Description

    ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.

    Reason

    The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated.

    Action

    Ascent sent an urgent medical device voluntary recall notification Letter and Response Form to each consignee on June 25, 2010. Consignees were requested to immediately examine their inventory of Ascent Reprocessed FemoStop devices with lot numbers located on an attached list; remove and quarantine all affected devices; complete the attached Recall Effectiveness Check Form; ship all affected product back to Ascent using the address indicated in the letter, and fax a completed Recall Effectiveness Check Form to 480-763-5350.

    Distribution

    Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.

    Quantity

    175 devices