Terumo APS 1

Serial numbers 0011 through 0395 may be affected.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.

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

Serial numbers 0006 through 0066 and 0100 through 0187 may be affected. Serial numbers 0046 and 0160 have been corrected.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.

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 number range 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.

Cardiovascular Devices

2

No

Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

Serial numbers 0031 through 0324 are potentially affected by the problem. Serial numbers 0092, 0128, 0152, 0223, 0226, 0237, 0246, 0260 and 0296 have been corrected.

Cardiovascular Devices

2

No

Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.

Serial numbers 0033 through 0355 are potentially affected by the problem. Serial numbers 0033, 0041, 0049, 0052, 0105, 0115, 0117, 0119, 0122, 0145, 0151, 0159, 0160, 0161, 0162, 0170, 0174, 0218, 0226, 0242, 0257, 0262, 0277, 0279, 0290, 0299, 0300, 0305, 0306, 0331, 0334, 0339, 0343 and 0360 have been corrected.

Cardiovascular Devices

2

No

Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.