BEUDAMED
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    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·April 9, 2025

    BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code MJC·October 16, 2017

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·April 18, 2024

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·April 4, 2019

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·May 15, 2024

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code QLN·January 18, 2023

    HEMOLUNG RAS

    FDA Adverse Event
    Malfunction ·ALUNG TECHNOLOGIES, INC.·Product code QLN·January 19, 2023

    SINGLE LUMEN PRESSURE MONITORING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·April 14, 2020

    SINGLE LUMEN PRESSURE MONITORING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·April 13, 2020

    SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·March 13, 2020

    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·June 8, 2016

    Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·June 8, 2016

    Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 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 Recall
    Terminated ·Navilyst Medical, Inc·Product code LJS·August 25, 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 Recall
    Terminated ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016

    Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016

    Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016

    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016

    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016