The Recall Desk
HighFDA (Devices)·Z-1689-2021·Announced 2021-06-09

Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk

Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a sterile medical device with a potential sterile barrier defect that could lead to infection. No illnesses or injuries have been reported. Under the severity rubric, this qualifies as a high-severity risk-of-harm product where injury has not yet been reported.

Plain-English summary

Vygon U.S.A. is recalling the Vygon Dressing Change w/ Maxiswab (Product Code: AMS-8465CS), a custom dressing change kit. A total of 8,320 units have been distributed in Pennsylvania. The product is being recalled because the Tyvek lid may not properly adhere to the tray, which can compromise the sterile barrier and potentially cause infection.

The affected lot is Lot Number 203373129, with an expiration date of June 30, 2022.

Those with this product should contact Vygon U.S.A. for recall information and instructions.

The recalled product

Product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Manufacturer
Vygon U.S.A.
Category
Medical Device — Surgical/Wound Care Dressing
Hazard
  • sterile-barrier-failure
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category