BEUDAMED
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    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

    FDA Enforcement
    Class II ·Terminated·Datascope Corporation·June 22, 2016

    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

    FDA Enforcement
    Class II ·Terminated·Datascope Corporation·April 19, 2017

    B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·June 18, 2010

    Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·June 18, 2010

    Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWF·June 18, 2010

    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·May 9, 2016

    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·February 16, 2017

    Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.

    FDA Enforcement
    Class III ·Terminated·LivaNova Deutschland GmbH·March 23, 2022

    Maquet HLM Tubing Pack; Bioline Coating

    FDA Recall
    Terminated ·Maquet Inc.·Product code DWE·July 13, 2010

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST ROLLER PUMPS, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-60 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    Stockert, S5 Double roller pump 85, Part 10-85-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST PUMPS 85 W/ COUPLING, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-62 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST ROLLER PUMP 85, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-70 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 MAST ROLLER PUMP, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-00 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400

    FDA Recall
    Terminated ·Maquet Inc.·Product code DWE·September 7, 2010