BEUDAMED
    FDA Recall 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 · Initiated May 12, 2014

    Recall

    Recall Number
    Z-1731-2014
    Event Number
    68267
    Firm
    Summit Medical, Inc.
    FEI Number
    3008719017
    Product Code
    ETD
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 12, 2014
    Posted
    June 9, 2014
    Terminated
    June 19, 2014
    Address
    815 Northwest Pkwy, Ste 100, Eagan, MN, 55121-1658

    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.

    Action

    Consignees was sent a Summit Medical "Medical Device Recall" letter, dated May 9, 2014. The letter described the problem and the product involved in the recall. Requested consignees to examine their inventory and to quarantine the product. Consignees need to immediately examine their inventory quarantine any affected product. Also, they are to complete and return the "Recall Response Form." For questions they can contact Nicole Dove at (651) 789-3921 or [email protected].

    Distribution

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

    Quantity

    9 boxes