—#128461

Product

Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: 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, theater shoes and other miscellaneous reusable items used in the care of patients.

FDA product code: MEC — Disinfector, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Serial Number Range: 3632511020 - 3613214010

Why it was recalled

STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.

Root cause (FDA determination)

Device Design

Action the firm took

Customers will be notified via onsite visits by STERIS Field Service Technicians to each affected Customer site. These visits will be documented and monitored until completion.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.

Timeline

Recall initiated: 2014-06-30
Posted by FDA: 2014-07-10
Terminated: 2015-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.