Device Recall Terumo Advanced Perfusion System 1

Serial numbers 0028 through 0111, 0113 through 0527, 0700 through 1310, 1358, 2322, 2325, 2327, 2328 and 2330 through 2333.

Cardiovascular Devices

2

No

Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. || The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment.

Serial numbers 0030, 0032 through 0587, 0700 through 1527, 1529, 1531 through 1533, 1563 through 1569, 1572, 1575, 1577 through 1581, 1584 through 1587, 1607, 2230 through 2235, 2239 through 2242, 2581 through 2583 and 2587 through 2594.

Cardiovascular Devices

2

No

Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. || The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment.

Serial Numbers: 0011 through 0610, 1001 through 1034, 1037 through 1049, 1100 and 1103 through 1174.

Cardiovascular Devices

2

No

Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, 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.

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. || The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.

Serial Numbers: 0006 through 0066, 0100 through 0322, 1001 through 1027 and 1100 through 1161.

Cardiovascular Devices

2

No

Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, 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.

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). || The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.

01198, 01205-01241, 01243-01281, 01283-01399, 01401-01404, 01406-01422, 01424-01433, 01435-01554, 01556-01564, 01565-01581, 01583-01609, 01611, 01613-01660, 01662-01721, 01724-01725.

Cardiovascular Devices

2

No

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

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.