BEUDAMED
    FDA Recall Terminated

    8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. 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. This 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.

    Recall: Z-1415-2009 · Initiated April 14, 2009

    Recall

    Recall Number
    Z-1415-2009
    Event Number
    51877
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 14, 2009
    Posted
    June 10, 2009
    Terminated
    February 9, 2010
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095

    Description

    8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. 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. This 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.

    Reason

    External tubing may separate during use, allowing blood loss.

    Action

    All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.

    Distribution

    Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.

    Quantity

    607