BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2352-2015 · Initiated June 29, 2015

    Recall

    Recall Number
    Z-2352-2015
    Event Number
    71694
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    GBQ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 29, 2015
    Posted
    August 7, 2015
    Terminated
    October 26, 2015
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    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.

    Action

    Merit Medical Systems sent an Urgent Product Recall Notice dated July 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions required of you: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. Due to the nature of this label discrepancy, you will need to physically verify whether product in inventory is within the scope of this recall. Your Merit Sales Representative can assist you with this determination. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Please work with your Merit Sales Representative to arrange product return. 4. If you have any questions concerning this communication, please don't hesitate to contact your Merit Sales Representative or call (801)208-4365.

    Distribution

    Nationwide Distribution including the Virgin Islands.

    Quantity

    950