# FDA recall Z-2519-2021

> **ConvaTec, Inc** · Class II · device recall initiated 2021-08-09.

## Product

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660)  DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957)  DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

## Reason for recall

There is a potential for open seals which can compromise sterility.

## Distribution

International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesia, Iran, Malaysia, Mexico, Myanmar, Nicaragua, New Zealand, Panama, Peru, , Pakistan, Paraguay, Qatar, Singapore, South Korea, Switzerland, Taiwan, Thailand, UAE, Uruguay, USA and Vietnam.

## Key facts

- **Recall number:** Z-2519-2021
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-09
- **Report date:** 2021-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greensboro, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2519-2021

## Citation

> AI Analytics. FDA recall Z-2519-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2519-2021. Source: US FDA. Licensed CC0.

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