BEUDAMED
    FDA Recall Terminated

    Hudson RICA Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.

    Recall: Z-1941-2009 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-1941-2009
    Event Number
    52823
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BZA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 31, 2009
    Posted
    September 16, 2009
    Terminated
    September 15, 2011
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    Hudson RICA Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.

    Reason

    The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.

    Action

    Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.

    Distribution

    U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).

    Quantity

    569,465 (total for all types)