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.

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.

On May 23, 2018, the firm notified affected customers by Urgent Device Field Correction letters distributed via FedEx. The letter stated that the system software had been updated to correct the issue, and that a STERIS service technician would be contacting each facility to perform the system software update. In the interim of the software update, users were instructed to continue to verify the units chemistry levels daily as part of the facilitys Quality Management System. Chemistry containers with low chemistry volume should be replaced prior to initiating the next cycle. If you have questions regarding this matter, please contact Katilin Slaper, Product Manager, at (440) 392-7431, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.