Device Recall Terumo APS 1

Serial numbers 1001 through 1008 and 4009 through 4269.

Cardiovascular Devices

2

No

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.

Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). || Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

Serial numbers 1001 through 1008 and 4009 through 4414.

Cardiovascular Devices

2

No

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.

Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump, Gray; Model 816571). || Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

Serial number 0188.

Cardiovascular Devices

2

No

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.

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump, Terumo Cardiovascular Systems, Ann Arbor, MI; Model 801041. || For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.

Cardiovascular Devices

2

No

Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.

Serial numbers 0093 and 0104 through 0114.

Cardiovascular Devices

2

No

Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763.