BEUDAMED
    FDA Recall 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 · Initiated April 20, 2018

    Recall

    Recall Number
    Z-1901-2018
    Event Number
    80072
    Firm
    LivaNova USA
    FEI Number
    1718850
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 20, 2018
    Posted
    May 18, 2018
    Terminated
    February 5, 2025
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    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.

    Action

    On 04/20/2018, a Medical Device Correction notice was sent to customers informing them to return devices less than ten years old. Returned devices will receive a deep cleaning service, which will reduce microbial contamination to HPC < 100 CFU/ml of water and NTM < 1 CFU/100ml.

    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