BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2532-2025
    Event ID
    97423
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Contract Medical International GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 17, 2025
    Initiation Date
    July 30, 2025
    Classification Date
    September 5, 2025
    Address
    Lauensteiner Str. 37, N/A, Dresden, N/A, N/A, Germany

    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.

    Code Info

    Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.

    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