# FDA recall Z-1695-2022

> **American Contract Systems, Inc.** · Class II · device recall initiated 2022-06-16.

## Product

Various Cysto Packs

## Reason for recall

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

## Distribution

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

## Key facts

- **Recall number:** Z-1695-2022
- **Recalling firm:** American Contract Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-16
- **Report date:** 2022-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kansas City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2022

## Citation

> AI Analytics. FDA recall Z-1695-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1695-2022. Source: US FDA. Licensed CC0.

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