BEUDAMED
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    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016

    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016

    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc·October 15, 2014

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc·October 15, 2014

    Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code FGE·February 4, 2011

    Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd. Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 --- The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code FGE·February 4, 2011

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx Only, For single use only --- Common Name: Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology - (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-320, UPN # - M001453200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN Product No. M001453050, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN Product No. M001453150, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010