BEUDAMED
    FDA Recall Terminated

    Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascular Systems, Ann Arbor, MI 48103

    Recall: Z-0532-2008 · Initiated September 19, 2007

    Recall

    Recall Number
    Z-0532-2008
    Event Number
    37989
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    KRL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 19, 2007
    Posted
    January 24, 2008
    Terminated
    July 7, 2009
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascular Systems, Ann Arbor, MI 48103

    Reason

    False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.

    Action

    Consignees were notified of the defect/issue and what to do if it were to occur (short term work around) via an Urgent Medical Device Removal letter dated 9/14/07. As the permanent fix users were informed the sensor will be replaced when replacements become available.

    Distribution

    Worldwide: USA, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Equador, Germany, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, Uruguay, Venezuela and Vietnam.

    Quantity

    175