BEUDAMED
    FDA Enforcement Class II Terminated

    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

    Recall: Z-2433-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2433-2019
    Event ID
    83468
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GETINGE US SALES LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 22, 2019
    Classification Date
    August 30, 2019
    Termination Date
    May 26, 2020
    Address
    45 BARBOUR POND DR, N/A, WAYNE, NJ, 07470, United States

    Description

    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

    Reason

    Reversed expiration and manufacturing date on the label

    Code Info

    Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988

    Distribution

    US nationwide distribution.

    Quantity

    1444 boxes worldwide