Devices

Device Recall Terumo APS 1

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
Cardiovascular Devices
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
Terumo Cardiovascular Systems Corporation
1 Event
- Recall of Device Recall Terumo APS 1

Manufacturer

Terumo Cardiovascular Systems Corporation

Manufacturer Address
Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA

20 devices with a similar name

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Device Recall Terumo APS 1

Model / Serial
Serial number 0188.
Product Classification
Cardiovascular Devices
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, 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.
Manufacturer
Terumo Cardiovascular Systems Corporation

Device Recall Terumo APS 1

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
Manufacturer
Terumo Cardiovascular Systems Corp

Device Recall Terumo APS 1

Model / Serial
Serial numbers 0093 and 0104 through 0114.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
Product Description
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763.
Manufacturer
Terumo Cardiovascular Systems Corp

Device Recall Terumo APS 1

Model / Serial
Serial numbers 0040 through 0044.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
Product Description
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).
Manufacturer
Terumo Cardiovascular Systems Corp

Device Recall Terumo APS 1

Model / Serial
Serial numbers 0011 through 0039 and 0041 through 0170.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Manufacturer
Terumo Cardiovascular Systems Corp

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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