# FDA recall Z-0525-2018

> **ConvaTec, Inc** · Class II · device recall initiated 2017-10-26.

## Product

SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802.    Intended for use as an ostomy protector providing a protective barrier to patient skin.

## Reason for recall

A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive  Skin Barrier (10 pack, 45 mm, REF 411803).

## Distribution

Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.

## Key facts

- **Recall number:** Z-0525-2018
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-26
- **Report date:** 2018-02-14
- **Termination date:** 2023-02-03

- **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-0525-2018

## Citation

> AI Analytics. FDA recall Z-0525-2018. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0525-2018. Source: US FDA. Licensed CC0.

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