BEUDAMED
    FDA Enforcement Class II Terminated

    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.

    Recall: Z-0067-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0067-2017
    Event ID
    75148
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brathwaites Oliver Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    August 19, 2016
    Classification Date
    October 11, 2016
    Termination Date
    July 19, 2019
    Address
    96 Terracon Place, N/A, Winnipeg, Manitoba, N/A, Canada

    Description

    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.

    Reason

    The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.

    Code Info

    Model OL-E12102, lot# 101615.

    Distribution

    U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT and NC.*** Foreign Consignee: Canada.

    Quantity

    760 units