# FDA recall Z-1134-2022

> **ConvaTec, Inc** · Class II · device recall initiated 2022-04-22.

## Product

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

## Reason for recall

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

## Distribution

Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.

## Key facts

- **Recall number:** Z-1134-2022
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-22
- **Report date:** 2022-06-01
- **Termination date:** 2026-03-04

- **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-1134-2022

## Citation

> AI Analytics. FDA recall Z-1134-2022. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-1134-2022. Source: US FDA. Licensed CC0.

---

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