BEUDAMED
    FDA Enforcement Class II Terminated

    ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

    Recall: Z-0041-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0041-2022
    Event ID
    88671
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ZOLL Circulation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    August 6, 2021
    Classification Date
    October 6, 2021
    Termination Date
    October 18, 2024
    Address
    2000 Ringwood Ave, San Jose, CA, 95131-1728, United States

    Description

    ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

    Reason

    Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

    Code Info

    All Lots

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.

    Quantity

    4,812 kits