Device Recall CDI 500 Blood Parameter Monitoring System

  • Model / Serial
    1193, 1355, 1356, 1420, 1423, 1464, 1465, 1504, 1521, 1522, 1523, 1524, 1526, 1527, 1529, 1530, 1602, 1603, 1604, 1606, 1662, 2035, 2102, 2103, 2104, 2105, 2106, 2107, 2800, 2901, 2902, 3131, 3132, 3133, 3134, 3135, 3261, 3262 and 4132.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
  • Product Description
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV, Terumo Cardiovascular Systems || The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
  • Source
    USFDA