Name: Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Creator: FDA
Published: 2012-07-25T00:00:00+00:00
Keywords: Class II

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[Enforcement] Terumo Cardiovascular Systems Corporation — Sarns Modular Perfusion Syste...

Jul 25, 2012

Published: 2012-07-25Captured: 2026-02-09Terumo Cardiovascular Systems CorporationProduct: Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion...

FDA issued a Class II enforcement action. Affects Terumo Cardiovascular Systems Corporation. Reason: Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with .

•Classification: Class II
•Firm: Terumo Cardiovascular Systems Corporation
•Status: Terminated
•Distribution: Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, B...

Reason

Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expr...

Status:Terminated

Distribution

Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Repu...

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