Reported Jun 9, 2021 · Ongoing

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

Vygon U.S.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vygon U.S.A. · 2750 Morris Rd Ste A200 · Lansdale, PA · 19446-6681

Is this the product you have?

  • Vygon Dressing
  • Change w/ Maxiswab - Product UsageCustom Dressing Change kit
  • Product CodeAMS-8465CS
Lot codes and dates
  • Lot Number203373129 Exp
  • Date
    • June 30
    • 2022
Amount recalled
8,320 units

Where it was sold

  • Nationwide
  • PA

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.