BEUDAMED
    FDA Enforcement Class I Terminated

    The Tri-Flo Subglottic Suction System

    Recall: Z-2826-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2826-2018
    Event ID
    80508
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    June 20, 2018
    Classification Date
    August 21, 2018
    Termination Date
    July 28, 2020
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420, United States

    Description

    The Tri-Flo Subglottic Suction System

    Reason

    Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.

    Code Info

    Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.

    Distribution

    Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.

    Quantity

    2150 Units Total