# FDA recall Z-2614-2021

> **ConvaTec, Inc** · Class II · device recall initiated 2021-08-20.

## Product

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

## Reason for recall

Primary packaging labeling may be incorrect.

## Distribution

Distribution in US and Canada    US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA

## Key facts

- **Recall number:** Z-2614-2021
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-20
- **Report date:** 2021-10-06

- **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-2614-2021

## Citation

> AI Analytics. FDA recall Z-2614-2021. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-2614-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*