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U.S. Department of Health and Human Services

Class 3 Device Recall Reliance 1227

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  Class 3 Device Recall Reliance 1227 see related information
Date Initiated by Firm June 30, 2014
Date Posted July 10, 2014
Recall Status1 Terminated 3 on July 01, 2015
Recall Number Z-2036-2014
Recall Event ID 68696
Product Classification Disinfector, medical devices - Product Code MEC
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.
Code Information Serial Number Range: 3632511020 - 3613214010
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Kathryn E. Cadorette
440-392-7601
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 37
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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