BEUDAMED
    FDA Enforcement Class II Terminated

    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090

    Recall: Z-0662-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0662-2019
    Event ID
    81210
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    October 5, 2018
    Classification Date
    December 22, 2018
    Termination Date
    March 25, 2021
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090

    Reason

    Potential for leakage due to defect in the thermoset check valve component.

    Code Info

    Item number: 41423-03. Lot numbers 3593903, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3593903. Lot number 3598129, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3598129. Expiration Date 12/01/2020.

    Distribution

    United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY

    Quantity

    1,760 units