Recall Z-2036-2014— Steris Corporation
Class III · Terminated
Class III FDA medical device recall by Steris Corporation, initiated 2014-06-30, terminated 2015-07-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-06-30
- Terminated
- 2015-07-01
- Firm location
- Mentor, OH, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.