# FDA recall Z-0401-2019

> **Safe N Simple, LLC** · Class II · device recall initiated 2018-08-22.

## Product

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345

## Reason for recall

The sterilization process used was unqualified.

## Distribution

CA

## Key facts

- **Recall number:** Z-0401-2019
- **Recalling firm:** Safe N Simple, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-22
- **Report date:** 2018-11-14
- **Termination date:** 2020-03-17

- **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-0401-2019

## Citation

> AI Analytics. FDA recall Z-0401-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0401-2019. Source: US FDA. Licensed CC0.

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