BEUDAMED
    FDA Enforcement Class II Terminated

    Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

    Recall: Z-2119-2014 · Reported August 6, 2014

    Enforcement

    Recall Number
    Z-2119-2014
    Event ID
    68757
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2014
    Initiation Date
    July 9, 2014
    Classification Date
    July 28, 2014
    Termination Date
    November 9, 2015
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000, United States

    Description

    Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

    Reason

    Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades.

    Code Info

    Product Code: 004434400, Lot number: 02A1402138

    Distribution

    US Distribution including the states of FL, GA, KY, MD, MS, MT, PA, SC and TX.

    Quantity

    120 units