Steris Corporation recalls Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and…

Recall date

May 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2392-2018

FDA classification

Class II

Brand / firm

Steris Corporation

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.