Vygon U.S.A.: Medical Device Recall in 2021 - (Recall #: Z-1689-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 15, 2021

Date Posted: June 9, 2021

Recall Number: Z-1689-2021

Event ID: 87802

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

Status: Ongoing

Product Quantity: 8,320 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of PA.

Voluntary or Mandated:

Voluntary: Firm initiated