29 results
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13ms
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Sources: EU EUDAMED, US FDA
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
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
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 Recall
Terminated
·LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany·Product code DWA·December 17, 2021
Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
FDA Recall
Terminated
·Carl Zeiss Meditec AG Carl-Zeiss-Promenade 10 Jena Germany·Product code HLM·August 6, 2020
Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWE·February 23, 2011