BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:

    Recall: Z-2532-2025 · Initiated July 30, 2025

    Recall

    Recall Number
    Z-2532-2025
    Event Number
    97423
    Firm
    Contract Medical International GmbH Lauensteiner Str. 37 Dresden Germany
    FEI Number
    3003637635
    Product Code
    DYB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 30, 2025
    Posted
    September 5, 2025

    Description

    Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:

    Reason

    Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

    Action

    On July 30, 2025, the firm notified affected consignees via email. Customers were instructed to verify if the labeling information on received products is consistent. If customers identify incorrect labeling, they should contact Contract Medical International GmbH for replacement.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, CT, FL, GA, KY, MA, MI, MO, NJ, NY, OR, RI, SC, TN, TX and the countries of Switzerland, Hungary, Italy, France, Denmark, Austria, Australia, Belgium, Poland, Germany, Bulgaria, Kazakhstan, Finland, Ireland, South Korea, Taiwan, Israel, Spain, Vietnam, Malaysia, Czechia, Thailand, Libya, Great Britain, Chile, Slovakia, Slovenia, Croatia, Sweden, Argentina.

    Quantity

    2500