BEUDAMED
    FDA Enforcement Class II Terminated

    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

    Recall: Z-2302-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2302-2018
    Event ID
    80250
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intersurgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 4, 2018
    Initiation Date
    April 25, 2018
    Classification Date
    June 27, 2018
    Termination Date
    April 9, 2019
    Address
    6757 Kinne St., E. Syracuse, NY, 13057, United States

    Description

    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

    Reason

    When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.

    Code Info

    0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.

    Distribution

    Distributors in IL, NJ, NV, TX, UT.

    Quantity

    1340