BEUDAMED
    FDA Recall Terminated

    Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.

    Recall: Z-0805-2010 · Initiated January 28, 2010

    Recall

    Recall Number
    Z-0805-2010
    Event Number
    54485
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    January 28, 2010
    Posted
    February 22, 2010
    Terminated
    April 27, 2010
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.

    Reason

    Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.

    Action

    Merit Medical Systems, Inc initiated customer notification by phone and letter beginning January 28, 2010. Consignees were instructed to immediately contact their affected customers, advise them of the recall activity and to identify and quarantine any unused inventory. A Recall Notification Form is to be completed and signed by the sales rep and by the site representative. Affected product is to returned to the firm. For further information, contact Merit Medical Systems, Inc. at 1-801-208-4228.

    Distribution

    Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.

    Quantity

    69 units