BEUDAMED
    FDA Enforcement Class II 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 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0866-2013
    Event ID
    64202
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 27, 2013
    Initiation Date
    January 16, 2013
    Classification Date
    February 20, 2013
    Termination Date
    September 16, 2015
    Address
    1600 West Merit Parkway, N/A, South Jordan, UT, 84095, United States

    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.

    Code Info

    Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.

    Distribution

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

    Quantity

    387 units