Lower risk Medical device recall · FDA · Published April 15, 2021

Vygon Dressing Kit Recall: Infection Risk from Poor Sterile Barrier

Vygon recalls custom dressing change kits with potential infection risk due to sterile barrier failure. Affected kits have lot number 203373129 expiring June 30, 2022.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1689-2021Medical device Vygon ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmVygon U.S.A.2750 Morris Rd Ste A200 · Lansdale, PA 19446-6681

✎ GovInfoNow plain-language explainer

Vygon is recalling custom dressing change kits that may have compromised sterile barriers, increasing infection risk. This affects kits with lot number 203373129 expiring June 30, 2022. Read more at govinfonow.com/recall/62781-vygon-dressing-kit-recall-infection-risk-from-poor-sterile-barrier.

Source Summary by GovInfoNow · govinfonow.com/recall/62781-vygon-dressing-kit-recall-infection-risk-from-poor-sterile-barrier · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1689-2021

Cite this page

“Vygon Dressing Kit Recall: Infection Risk from Poor Sterile Barrier.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62781-vygon-dressing-kit-recall-infection-risk-from-poor-sterile-barrier. Based on FDA recall #Z-1689-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1689-2021%22&limit=1).

Vygon U.S.A. voluntarily recalled Vygon Dressing Change w/ Maxiswab kits on April 15, 2021, according to the FDA. The product has compromised sterile barriers that may cause infection.

How to tell if you have it

Brand: Vygon
Product: Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit
Product Code: AMS-8465CS
Lot Number: 203373129
Exp. Date: June 30, 2022

The hazard

The recall involves compromised sterile barriers because the Tyvek Lid is not properly adhering to the Tray. This defect has the potential to cause an infection.

Context

GovInfoNow's records show Vygon U.S.A. has two other recalls on record since February 28, 2018. On December 6, 2018, Vygon issued a recall for DualStop White Caps due to leaks risk in intravascular lines. Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026) and Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (June 12, 2026).

How to tell if you have this one

Check for lot number 203373129 on the kit packaging. The product expires June 30, 2022. This specific kit includes the Maxiswab component.

Brand
Vygon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for lot number 203373129 and expiration date June 30, 2022 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 55 days after the firm started it.

Apr 15, 2021Firm started the recall
May 28, 2021FDA classified it Class II
Jun 9, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62781-vygon-dressing-kit-recall-infection-risk-from-poor-sterile-barrier">Vygon Dressing Kit Recall: Infection Risk from Poor Sterile Barrier (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1689-2021 (April 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1689-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.