# FDA recall Z-2392-2018

> **Steris Corporation** · Class II · device recall initiated 2018-05-23.

## Product

Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003    Product Usage:  The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the care of patients.

## Reason for recall

The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s  Chemical Low Level  alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.

## Distribution

Worldwide Distribution - US Nationwide in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-2392-2018
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-23
- **Report date:** 2018-07-18
- **Termination date:** 2019-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2018

## Citation

> AI Analytics. FDA recall Z-2392-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2392-2018. Source: US FDA. Licensed CC0.

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