BEUDAMED
    FDA Enforcement Class II Terminated

    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

    Recall: Z-1437-2020 · Reported March 11, 2020

    Enforcement

    Recall Number
    Z-1437-2020
    Event ID
    84880
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Organ Recovery Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2020
    Initiation Date
    January 30, 2020
    Classification Date
    March 4, 2020
    Termination Date
    September 30, 2021
    Address
    1 Pierce Pl Ste 475W, N/A, Itasca, IL, 60143-2618, United States

    Description

    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

    Reason

    Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

    Code Info

    LKT2000 Lots 119944, 119765, 119648, 120055, 120242.

    Distribution

    Distributed nationwide (32 states) and to Canada.

    Quantity

    2274