BEUDAMED
    FDA Recall Terminated

    Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.

    Recall: Z-1891-2009 · Initiated July 6, 2009

    Recall

    Recall Number
    Z-1891-2009
    Event Number
    52782
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 6, 2009
    Posted
    August 26, 2009
    Terminated
    August 24, 2010
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.

    Reason

    The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.

    Action

    Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee.

    Distribution

    Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France and Japan.

    Quantity

    1160 total