# FDA recall Z-1689-2021

> **Vygon U.S.A.** · Class II · device recall initiated 2021-04-15.

## Product

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

US Nationwide distribution in the state of PA.

## Key facts

- **Recall number:** Z-1689-2021
- **Recalling firm:** Vygon U.S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-15
- **Report date:** 2021-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lansdale, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2021

## Citation

> AI Analytics. FDA recall Z-1689-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1689-2021. Source: US FDA. Licensed CC0.

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