FDA (Devices) recall action 79752

Vygon U.S.A. recalled 8 products on 2018-05-16

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2018-05-16
Critical: 0
Units: 132,160

Why these products were recalled

Potential friction holes may affect the sterility of the product.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2018-05-16
Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise
Vygon U.S.A. is recalling Maximum Barrier Insertion Trays because potential friction holes may affect the product's sterility.
Product
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states
HighFDA (Devices)··2018-05-16
Vygon Recalls PICC Insertion Trays Due to Potential Sterility Issues
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the sterility of the product.
Product
PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states
HighFDA (Devices)··2018-05-16
Vygon Recalls Maximum Barrier Tray Due to Potential Sterility Compromise
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code MCITX-1) because potential friction holes may affect the product's sterility.
Product
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states
HighFDA (Devices)··2018-05-16
Vygon Recalls Neonatal PICC Trays Due to Potential Sterility Issues
Vygon U.S.A. is recalling 16,520 Neonatal PICC Trays because potential friction holes may affect the product's sterility.
Product
Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states
HighFDA (Devices)··2018-05-16
Vygon Recalls PICC Trays Due to Potential Sterility Compromise
Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.
Product
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states
HighFDA (Devices)··2018-05-16
Vygon Recalls PICC Insertion Trays Due to Potential Sterility Compromise
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's sterility.
Product
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states
HighFDA (Devices)··2018-05-16
Vygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product sterility.
Product
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states
HighFDA (Devices)··2018-05-16
Vygon Recalls PICC Insertion Kits Due to Sterility Risk
Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.
Product
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Category
Distribution
13 states