Devices

Device Recall Sarns 8000 Roller pump

Model / Serial
Lots 19937-19944, 19955-19984, 20005-20029, 20035-20038 and 20047.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
Product Description
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
Manufacturer
Terumo Cardiovascular Systems Corporation
1 Event
- Recall of Device Recall Sarns 8000 Roller pump

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

One device with a similar name

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Device Recall Sarns 8000 Roller pump

Model / Serial
lots 19945-19954 and 19985-20001.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
Product Description
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
Manufacturer
Terumo Cardiovascular Systems Corporation

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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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