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PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT

FDA Recall
Terminated ·CTI PET Systems Inc·Product code KPS·May 27, 2004

Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.

FDA Recall
Terminated ·Diasorin Inc.·Product code MSV·October 26, 2004

BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

BD Vacutainer Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

BD Vacutainer EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

BD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI)

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code FPA·May 9, 2018

Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged, product code: 340-4165, Method of Sterilization using Ethylene Oxide.

FDA Recall
Terminated ·MOOG Medical Devices Group·Product code FPK·May 18, 2012

Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code GKZ·April 14, 2011

VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath, Catalog No./REF 11402001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath, Catalog No./REF 11402002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NT FRS 65cm Kit w/19Ga Needle, Catalog No./REF 11403006, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure NeverTouch FRS 45cm Clear Needle, Catalog No./REF 51403001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Procedure Kit 45cm, Catalog No./REF 51402007, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit w/Gripper and RFID T, Catalog No./REF 11403002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, 45cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403012, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit w/Gripper and RFID T, Catalog No./REF 11403001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Procedure Kit 65cm, Catalog No./REF 51402008, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011

VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm Kit, Catalog No./REF 11403004, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

FDA Recall
Terminated ·Angiodynamics Worldwide Headquarters·Product code GEX·November 10, 2011