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Sources: EU EUDAMED, US FDA
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The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·March 1, 2017
Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTY·November 1, 2010
Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTY·November 1, 2010
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
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·October 2, 2013
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 7, 2008
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·May 27, 2015
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 7, 2008
Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI. The sternal saw blades are indicated for use in medial sternotomoties. The saw blades are used wit the Sarns Sternal Saw System.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GFA·October 20, 2010
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code OEZ·May 12, 2017
Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·December 2, 2010
Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·December 2, 2010
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·November 1, 2010
CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.
FDA Recall
Terminated
·Terumo Cardiovascular Corporation·Product code DTN·July 21, 2011
Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI. The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated for use with the Terumo VirtuoSaph Endoscopic Vein Harvesting System and a compatible generator during saphenous vein harvesting procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GCJ·January 10, 2011
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWC·March 16, 2018
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWC·March 16, 2018
Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·July 6, 2009
Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KFM·July 6, 2009