BEUDAMED
    FDA Enforcement Class II 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 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1776-2018
    Event ID
    79750
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Transonic Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    February 15, 2018
    Classification Date
    May 9, 2018
    Termination Date
    April 30, 2019
    Address
    34 Dutch Mill Rd, N/A, Ithaca, NY, 14850-9785, United States

    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.

    Code Info

    Lots B151130E2 and B161115E0

    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