BEUDAMED
    FDA Enforcement Class II Terminated

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    Recall: Z-1901-2018 · Reported May 30, 2018

    Enforcement

    Recall Number
    Z-1901-2018
    Event ID
    80072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 30, 2018
    Initiation Date
    April 20, 2018
    Classification Date
    May 18, 2018
    Termination Date
    February 5, 2025
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    Reason

    Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.

    Code Info

    Serial #: a) 16S10743 - 6S11708 b) 16S10772 - 16S16840 C) 16S10958 - 16S16847

    Distribution

    MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,

    Quantity

    2408