Home / Recalls / Vygon U.S.A. / Z-1114-2019

Z-1114-2019 Class II Terminated

Recalled by Vygon U.S.A. — Lansdale, PA

Recall Details

Product Type
Devices
Report Date
April 17, 2019
Initiation Date
December 6, 2018
Termination Date
May 12, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
339,800

Product Description

Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

Reason for Recall

DualStop Caps defect causing leaks in affected product

Distribution Pattern

US Nationwide distribution.

Code Information

Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD

Other recalls by Vygon U.S.A.

  • Z-1689-2021 Class II — Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, P (April 15, 2021)
  • Z-1115-2019 Class II — Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Pr (December 6, 2018)
  • Z-1634-2018 Class II — Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insert (February 28, 2018)
  • Z-1639-2018 Class II — PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the inser (February 28, 2018)
  • Z-1633-2018 Class II — PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs (February 28, 2018)
  • Z-1636-2018 Class II — Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for (February 28, 2018)
  • Z-1637-2018 Class II — PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PIC (February 28, 2018)
  • Z-1635-2018 Class II — Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insert (February 28, 2018)
  • Z-1640-2018 Class II — PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the inser (February 28, 2018)
  • Z-1638-2018 Class II — Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion (February 28, 2018)