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Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial
Recalled October 3, 2012 · FDA recall Z-2449-2012 · Terumo Cardiovascular Systems
Hazard
Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat · FDA Class II
Units
72 units
Sold at
Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.
Description
Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat
Product
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →