Device Recall Terumo APS 1

  • Model / Serial
    Serial numbers 0011 through 0363 may be affected. Serial numbers 0011, 0014, 0023, 0038, 0043, 0047, 0119, 0145, 0245, 0253, 0254, 0256, 0260, 0265, 0278, 0280, 0284, 0295, 0305, 0310, 0317, 0333, 0341, 0343, 0351, 0356 and 0360 have been corrected and the other serial numbers listed will be corrected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.
  • Product Description
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA

20 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial numbers 0028 through 0111, 0113 through 0527, 0700 through 1528, 1539 through 1579, 2000 through 2392 and 2395 through 2466.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Belgium. Canada, Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). || Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
  • Manufacturer
  • Model / Serial
    Serial numbers 0030, 0032 through 0587, 0700 through 1936, 1947 through 1951 and 2000 through 2799.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Belgium. Canada, Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041). || Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
  • Manufacturer
  • Model / Serial
    Serial number 0727.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802110. || For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
  • Model / Serial
    Serial numbers 00001 through 01246, 01257 through 01277, 01279 through 01286, 01288 through 01295, 01298 through 01308, 01310 through 01315 and 01319 through 01320.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 Pressure Monitoring Unit, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802112. || For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
  • Model / Serial
    Serial number 0637.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • Product Description
    Terumo Advanced Perfusion System 1 Temperature Monitoring Systems, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802114. || For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
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