BEUDAMED
    FDA Enforcement Class I Terminated

    Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.

    Recall: Z-1956-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-1956-2019
    Event ID
    83202
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2019
    Initiation Date
    June 7, 2019
    Classification Date
    July 30, 2019
    Termination Date
    July 28, 2020
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.

    Reason

    Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.

    Code Info

    Lot 2018110290

    Distribution

    Distributed to one account in Arkansas.

    Quantity

    80 kits