Vygon U.S.A.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1689-2021Class IIVygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-846April 15, 2021
Z-1114-2019Class IIVygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap usedDecember 6, 2018
Z-1115-2019Class IIVyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap useDecember 6, 2018
Z-1639-2018Class IIPICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into tFebruary 28, 2018
Z-1633-2018Class IIPICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular sFebruary 28, 2018
Z-1636-2018Class IIMaximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICFebruary 28, 2018
Z-1637-2018Class IIPICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascularFebruary 28, 2018
Z-1635-2018Class IIMaximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into thFebruary 28, 2018
Z-1640-2018Class IIPICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into tFebruary 28, 2018
Z-1638-2018Class IIMaximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vFebruary 28, 2018
Z-1634-2018Class IINeonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into thFebruary 28, 2018