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Class 3 Device Recall Reliance 1227 |
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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
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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.
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Code Information |
Serial Number Range: 3632511020 - 3613214010 |
Recalling Firm/ Manufacturer |
Steris Corporation 5960 Heisley Rd Mentor OH 44060-1834
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For Additional Information Contact |
Kathryn E. Cadorette 440-392-7601
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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.
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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
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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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