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Terumo Cardiovascular Systems Corporation - Terumo HX2 Temperature Management System - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the at...
Source: Medical Device Recalls - May 29, 2015 Category: Medical Equipment Source Type: alerts

Ethicon Endo-Surgery Inc - Echelon Flex Powered Vascular Stapler With Advanced Placement Tip and White Reloads - Class 2 Recall
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2015 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo HX2 Temperature Management System - Class 2 Recall
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2015 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Maquet QuadroxID Pediatric Diffusion Membrane Oxygenator - Class 2 Recall
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 25, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Conducer Cardioplegia Set SITH MP4 - Class 2 Recall
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Custom Cardiovascular and Perfusion Procedure Kits - Class 2 Recall
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Modified MP4Cardioplegia Delivery System with Conducer - Class 2 Recall
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Clear Cardioplegia Delivery Sets - Class 2 Recall
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2014 Category: Medical Equipment Source Type: alerts

Justright Surgical, LLC - JustRight 5mm Stapler - Class 2 Recall
Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Medtronic Cardiovascular Surgery-the Heart Valve Division - Hancock Apical Left Ventricular Connector (LV Connector) - Class 2 Recall
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns SoftFlow Aortic Cannulae - Class 2 Recall
Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo TenderFlow Pediatric Venous Cannulae - Class 2 Recall
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo Dualstage Venous Return Cannulae - Class 2 Recall
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2014 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - CPB Catheter Kit - Class 2 Recall
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 2014 Category: Medical Equipment Source Type: alerts