Recall Z-2392-2018— Steris Corporation

Class II FDA medical device recall by Steris Corporation, initiated 2018-05-23, terminated 2019-11-05. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

Steris Corporation

Classification

Class II

Status

Terminated

Initiated

2018-05-23

Terminated

2019-11-05

Firm location

Mentor, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.