Home / Recalls / Vygon U.S.A. / Z-1636-2018

Z-1636-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
February 28, 2018
Termination Date
February 19, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16520 total products

Product Description

Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

Reason for Recall

Potential friction holes may affect the sterility of the product.

Distribution Pattern

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Code Information

Lot Numbers: 17F001D & 17K038D UDI: 08498840004814

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-1114-2019 Class II — Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Pro (December 6, 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-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)
  • Z-1634-2018 Class II — Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insert (February 28, 2018)