Home / Recalls / Vygon U.S.A. / Z-1689-2021

Z-1689-2021 Class II Ongoing

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

FDA device recall Z-1689-2021 was initiated by Vygon U.S.A. on April 15, 2021 and is designated Class II. Reason for recall: Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection The recall status is ongoing. Affected quantity: 8,320 units.

Recall Details

Product Type
Devices
Report Date
June 9, 2021
Initiation Date
April 15, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,320 units

Product Description

Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

Reason for Recall

Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection

Distribution Pattern

US Nationwide distribution in the state of PA.

Code Information

Lot Number: 203373129 Exp. Date: June 30, 2022

Other recalls by Vygon U.S.A.

  • Z-1114-2019 Class II — Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Pro (December 6, 2018)
  • 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-1637-2018 Class II — PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PIC (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-1633-2018 Class II — PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs (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-1636-2018 Class II — Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for (February 28, 2018)
  • Z-1635-2018 Class II — Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insert (February 28, 2018)

FDA data resources