BEUDAMED
    FDA Recall Terminated

    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090

    Recall: Z-0661-2019 · Initiated October 5, 2018

    Recall

    Recall Number
    Z-0661-2019
    Event Number
    81210
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    KRB
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    October 5, 2018
    Terminated
    March 25, 2021
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090

    Reason

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

    Action

    On October 5, 2018, ICU Medical URGENT MEDCAL DEVICE RECALL letters were sent to ICU Medical's consignees advising them of this matter. Each letter contained a response form and a return label.

    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

    27,250 units total