BEUDAMED
    FDA Recall Terminated

    SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

    Recall: Z-1099-2019 · Initiated September 14, 2018

    Recall

    Recall Number
    Z-1099-2019
    Event Number
    82365
    Firm
    LivaNova USA Inc.
    FEI Number
    1718850
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 14, 2018
    Terminated
    September 14, 2022
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

    Reason

    For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

    Action

    The recalling firm, LivaLova, contacted the first customer by phone on 9/14/2018 followed by an "IMPORT" letter, the first of which was dated 9/18/2018. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: keep these devices out of service until the investigation is complete. To return your device, please email [email protected]. If taking Serial Numbers 16S15335 and 16S15337 out of service will negatively impact your clinical practice, we can arrange for delivery of loaner devices during this investigation and,as necessary, while they undergo repeat Deep Cleaning Process. If you have any questions, contact V.P., Clinical, Quality, and Regulatory Services at 303-467-6306 or email: [email protected].

    Distribution

    US Distribution to states of: IN, MO, and OH.

    Quantity

    6 devices