BEUDAMED
    FDA Recall Terminated

    7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

    Recall: Z-1497-2017 · Initiated February 16, 2017

    Recall

    Recall Number
    Z-1497-2017
    Event Number
    76596
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 16, 2017
    Posted
    March 24, 2017
    Terminated
    August 8, 2017
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

    Reason

    Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.

    Action

    Consignees notified on 2/16/17 to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.

    Distribution

    Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.

    Quantity

    1,265 total