BEUDAMED
    FDA Recall Terminated

    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

    Recall: Z-1776-2018 · Initiated February 15, 2018

    Recall

    Recall Number
    Z-1776-2018
    Event Number
    79750
    Firm
    Transonic Systems Inc
    FEI Number
    1319030
    Product Code
    PEH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 15, 2018
    Terminated
    April 30, 2019
    Address
    34 Dutch Mill Rd, Ithaca, NY, 14850-9785

    Description

    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

    Reason

    The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

    Action

    The recalling firm has sent all of its customers a Recall Notification Letter dated February 15, 2018, and has included a Customer Reponse Form that requests that customers either return or destroy the ADT1018 Tubing in their possession. For further questions, please call (800) 353-3569.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.

    Quantity

    6044