BEUDAMED
    FDA Enforcement Class II Terminated

    154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    Recall: Z-0958-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-0958-2021
    Event ID
    86973
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2021
    Initiation Date
    December 2, 2020
    Classification Date
    February 5, 2021
    Termination Date
    June 30, 2023
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    Reason

    Due to the incorrect filter assembly.

    Code Info

    Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.

    Quantity

    Total Kits = 7,500 for all four lots