BEUDAMED
    FDA Recall Terminated

    SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x 26cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.

    Recall: Z-2224-2008 · Initiated May 20, 2008

    Recall

    Recall Number
    Z-2224-2008
    Event Number
    48688
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa
    FEI Number
    2027111
    Product Code
    FAD
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 20, 2008
    Posted
    September 16, 2008
    Terminated
    April 14, 2010
    Address
    Margarita, CA, 92688-2650

    Description

    SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x 26cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.

    Reason

    The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

    Action

    On May 20, 2008, Applied Medical began distribution of an Recall Notice with fax-back attachment ( Recall Notification Confirmation Form ) to all customers in the United States via Applied's Direct Sales Force. The Notice informed customers of the problem that caused the initiation of the recall and requested they complete and fax-back the Recall Notification Confirmation Form . The letter also instructed their customers to remove and return affected product to Applied Medical immediately via FedEx. If the customers had an questions they were to contact Mr. Frans VandenBroek at (949) 7l3-8369 or by e-mail at fvandenbroekappliedmedical.com.

    Distribution

    Nationwide to: AL, AZ, CA, CO, DC, FL, GA, KY, IL, LA, MI, MN, NC, NJ, NY, PA, TN, TX, WA, WI and Worldwide to: Australia & South Africa

    Quantity

    30