BEUDAMED
    FDA Recall Terminated

    CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

    Recall: Z-1841-2012 · Initiated May 9, 2012

    Recall

    Recall Number
    Z-1841-2012
    Event Number
    61742
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 9, 2012
    Posted
    June 20, 2012
    Terminated
    July 11, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

    Reason

    During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti

    Action

    Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advises customers to discontinue use of the affected product and to return the product to the firm. A Response Form was attached for customers to complete and return. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam.

    Quantity

    133,793 (each)