BEUDAMED
    FDA Recall Terminated

    Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.

    Recall: Z-0882-2011 · Initiated December 2, 2010

    Recall

    Recall Number
    Z-0882-2011
    Event Number
    57416
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 2, 2010
    Posted
    January 7, 2011
    Terminated
    April 17, 2012
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.

    Reason

    The firm identified that a component within the System 1 ABD and Occluder Modules that may malfunction. The Air Bubble Detector Module (ABD) is used with an air sensor to detect gross air bubbles in the perfusion circuit. The Occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line. The firm identified a fai

    Action

    Terumo Cardiovascular Systems Corporation issued an URGENT MEDICAL DEVICE CORRECTION letter dated 12/2/2010 to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager. The letter identified the product, the problem, and the action to be taken. The letter stated the firm will replace all modules in the affected population, and that a representative would contact the consignee regarding the replacement schedule. Customers were to review the Medical Device Correction. Assure that all user were aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call 1-800-521-2818.

    Distribution

    Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam

    Quantity

    508 devices