BEUDAMED
    FDA Enforcement Class II Terminated

    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

    Recall: Z-2352-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2352-2015
    Event ID
    71694
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    June 29, 2015
    Classification Date
    August 7, 2015
    Termination Date
    October 26, 2015
    Address
    1600 West Merit Parkway, N/A, South Jordan, UT, 84095, United States

    Description

    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

    Reason

    Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.

    Code Info

    Lot No: E796578 E796579 MR792035 MR786325 MR797946 MR791206 MR791212 MR786923 E796605 MR786311 MR791660 E796647 RL MR795466 MR786301 E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318 MR786319

    Distribution

    Nationwide Distribution including the Virgin Islands.

    Quantity

    950