BEUDAMED
    FDA Recall Terminated

    Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240. Level Sensor pads are used to attach the level sensor to the sides of a rigid reservoir.

    Recall: Z-0311-2009 · Initiated January 13, 2008

    Recall

    Recall Number
    Z-0311-2009
    Event Number
    46314
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 13, 2008
    Posted
    December 10, 2008
    Terminated
    July 7, 2009
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240. Level Sensor pads are used to attach the level sensor to the sides of a rigid reservoir.

    Reason

    The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.

    Action

    Consignees were notified via recall letter (Urgent Medical Device Removal letter) dated 2/13/08 and requested to report stocks on hand so that replacements could be sent.

    Distribution

    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Japan, Saudi Arabia, Singapore and Yemen.

    Quantity

    31,980 pads (25,620 to U.S. and 6,360 international)