Device Recall Terumo APS 1

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.

Serial numbers 0040 through 0044.

Cardiovascular Devices

2

No

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

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).

Serial numbers 0006 through 0066.

Cardiovascular Devices

2

No

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

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

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.

Cardiovascular Devices

2

No

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.

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