BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.

    Recall: Z-1938-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1938-2016
    Event ID
    74034
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    May 5, 2016
    Classification Date
    June 9, 2016
    Termination Date
    August 25, 2017
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.

    Reason

    The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.

    Code Info

    Lot 73F1500606

    Distribution

    US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.

    Quantity

    6,390 ea.