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    Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTS·February 5, 2008

    Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo Cardiovascular Systems, Ashland, MA 0172 Item Number: 71038-05 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KRI·August 12, 2011

    Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number 72990 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item Number: 73413 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item Number: 73381 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK Item Number 73192 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·July 18, 2008

    Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not distributed in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·July 18, 2008

    Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240. Level Sensor pads are used to attach the level sensor to the sides of a rigid reservoir.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·January 13, 2008

    Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code GFA·February 14, 2008

    System 1 Base 220V, Catalog 801764, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 31, 2011

    System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 31, 2011

    Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code GFA·February 14, 2008

    Large Roller Pump 6" Diameter, Catalog 801041, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 31, 2011

    Large Roller Pump 6" Diameter, Catalog 816571, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 31, 2011

    Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 11, 2010

    Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. The Terumo Advanced Perfusion System 1 is 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.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·February 14, 2011