# FDA recall Z-0233-2020

> **ConvaTec, Inc** · Class II · device recall initiated 2019-09-06.

## Product

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands:   1) Combihesive Natura Durahesive  2) SurFit Natura Durahesive  3) Natura  4) Varicare    Product Usage: stoma management

## Reason for recall

ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.

## Distribution

Worldwide distributions.

## Key facts

- **Recall number:** Z-0233-2020
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-06
- **Report date:** 2019-11-06
- **Termination date:** 2022-11-30

- **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-0233-2020

## Citation

> AI Analytics. FDA recall Z-0233-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0233-2020. Source: US FDA. Licensed CC0.

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