# FDA recall Z-2330-2018

> **Safe N Simple, LLC** · Class II · device recall initiated 2012-06-18.

## Product

Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

## Reason for recall

The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.

## Distribution

Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.

## Key facts

- **Recall number:** Z-2330-2018
- **Recalling firm:** Safe N Simple, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2012-06-18
- **Report date:** 2018-07-04
- **Termination date:** 2020-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clarkston, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2018

## Citation

> AI Analytics. FDA recall Z-2330-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2330-2018. Source: US FDA. Licensed CC0.

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