BEUDAMED
    FDA Recall Terminated

    ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

    Recall: Z-0613-2009 · Initiated November 7, 2008

    Recall

    Recall Number
    Z-0613-2009
    Event Number
    50193
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2008
    Posted
    January 13, 2009
    Terminated
    August 5, 2009
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095

    Description

    ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

    Reason

    Biliary drainage catheter tips may separate from the catheter shaft after placement.

    Action

    Customers were notified by Merit representatives by phone or visit beginning 11/07/2008. They were to identify and quarantine any unused inventory and complete a Product Retrieval Form. For further information, call 800-356-3748 x 4929.

    Distribution

    Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.

    Quantity

    244 units