BEUDAMED
    FDA Enforcement Class II Terminated

    Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.

    Recall: Z-1731-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1731-2014
    Event ID
    68267
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Summit Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    May 12, 2014
    Classification Date
    June 9, 2014
    Termination Date
    June 19, 2014
    Address
    815 Northwest Pkwy Ste 100, N/A, Eagan, MN, 55121-1658, United States

    Description

    Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.

    Reason

    One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.

    Code Info

    Lot #: 147809

    Distribution

    Worldwide Distribution -- USA, including CA, and GERMANY.

    Quantity

    9 boxes