Vygon Corporation

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0113-2015Class IIBionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-lesAugust 28, 2014
Z-0937-2013Class IIChurchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC wDecember 17, 2012
Z-1798-2012Class IIVygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syriMay 11, 2012
Z-1799-2012Class IIVygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syriMay 11, 2012
Z-1797-2012Class IIVygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringMay 11, 2012
Z-1807-2012Class IIChurchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are usMay 11, 2012
Z-1801-2012Class IIVygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syrMay 11, 2012
Z-1802-2012Class IIChurchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included inMay 11, 2012
Z-1808-2012Class IIChurchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included iMay 11, 2012
Z-1803-2012Class IIChurchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are uMay 11, 2012
Z-1800-2012Class IIVygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syrMay 11, 2012
Z-1804-2012Class IIChurchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes includMay 11, 2012
Z-1805-2012Class IIChurchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are usMay 11, 2012
Z-1806-2012Class IIChurchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are usMay 11, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K241587pilot TLSFebruary 26, 2025