BEUDAMED
    FDA Enforcement Class II Terminated

    SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

    Recall: Z-0789-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0789-2022
    Event ID
    89510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sam Medical Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2022
    Initiation Date
    January 28, 2022
    Classification Date
    March 16, 2022
    Termination Date
    April 6, 2023
    Address
    12200 SW Tualatin Rd Suite 200, N/A, Tualatin, OR, 97062, United States

    Description

    SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

    Reason

    Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.

    Code Info

    Model Number: CS203-EN UDI Code: (01)10822045000190(10)Y060321-09(17)270601 (Case Carton) UDI Code: (01)10822045000193(10)Y060321-09(17)270601 (Each Pouch/Package) Lot Number: Y060321-09

    Distribution

    U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada

    Quantity

    2,950 packages