BEUDAMED
    FDA Recall Terminated

    Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.

    Recall: Z-0866-2013 · Initiated January 16, 2013

    Recall

    Recall Number
    Z-0866-2013
    Event Number
    64202
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 16, 2013
    Posted
    February 20, 2013
    Terminated
    September 16, 2015
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.

    Reason

    A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.

    Action

    Merit initiated the recall on January 16, 2013. A voicemail script notification to users and Q&A document was provided to those sales representative that had received and or distributed product. On January 16, 2013, Merit sales representatives began contacting each physician and/or user facility that had been provided product. Written communication distribution began on 22 January 2013. Affected sales representatives, physicians, and hospitals were provided written identification information, instruction to not distribute or continue placing these devices, and on how to return any unused product if applicable. All product on hand at Merit was inventoried and remains under quarantined status. Further questions please call (801) 208-4301,

    Distribution

    Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark

    Quantity

    387 units