Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Roller Pump - Class 2 Recall
Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2020 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Roller Pump - Class 2 Recall
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2020 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Roller Pump - Class 2 Recall
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2020 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Roller Pump - Class 2 Recall
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2020 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Arterial Filter, Uncoated, 38um - Class 2 Recall
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2019 Category: Medical Devices Source Type: alerts
Edwards Lifesciences, LLC - Edwards Lifesciencese Aortic Perfusion Cannulae - Class 2 Recall
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hour...
Source: Medical Device Recalls - November 19, 2019 Category: Medical Devices Source Type: alerts
LivaNova USA Inc. - Stockert HeaterCooler System 3T - Class 2 Recall
SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volume 6 liters. " One interchangeable heating/cooling circuit for cardioplegia heat-exchanger, temperatures ranging from 2 ...
Source: Medical Device Recalls - October 26, 2019 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) - Class 2 Recall
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2019 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Electronic Patient Gas System - Class 2 Recall
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2019 Category: Medical Devices Source Type: alerts
LivaNova USA Inc. - Stockert/Sorin HeaterCooler System 3T - Class 2 Recall
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 7, 2019 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - RESERVOIR Y ADAPTER - Class 2 Recall
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2019 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - SUCTION / ANTICOAGULATION ASSEMBLY - Class 2 Recall
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2019 Category: Medical Devices Source Type: alerts
LivaNova USA - Perfusion Tubing Set - Class 2 Recall
Perfusion Pack, Rx only, Sterile EO (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2019 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 Electronic Patient Gas System - Class 2 Recall
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 19, 2018 Category: Medical Devices Source Type: alerts
Datascope Corporation - Maquet Inc. - Class 2 Recall
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 12, 2018 Category: Medical Devices Source Type: alerts
