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U.S. Department of Health and Human Services

Class 2 Device Recall RELIANCE 130 and 130L CART WASHER

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  Class 2 Device Recall RELIANCE 130 and 130L CART WASHER see related information
Date Initiated by Firm July 14, 2012
Date Posted August 01, 2012
Recall Status1 Terminated 3 on June 06, 2014
Recall Number Z-2122-2012
Recall Event ID 62557
Product Classification Disinfector Medical Device - Product Code MEC
Product The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.
Code Information The codes for the product are Julian date-coded. They follow the following pattern: AABBBCCDDD AA is a two digit code representing the manufacturing facility number BBB is a three digit code representing the day of the year that the device was manufactured CC is a two digit code representing the Julian year that the device was manufactured DDD is a three digit code representing the number of the number of the device manufactured that day.  For example, a serial number of 3606499005 indicates that the device was manufactured in facility number 36, on the 64th day of the year of 1999, and the device was the 5th device manufactured that day.  The serial number ranges for the devices being recalled are: RELIANCE¿ 130: 3606499005  3626709006 RELIANCE¿ 130L: 3629299006  3628809011
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Lindsay Benz
440-392-7075
Manufacturer Reason
for Recall		 To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on your cart washer.
FDA Determined
Cause 2		 Labeling design
Action Steris Corp. sent a Urgent Field Correction Notice dated July 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To ensure users are properly operating the Reliance 130 and 130L Cart Washers a 'door close' confirmation button and a door open delay will be installed on the affected cart washer(s). A STERIS Service Representative will contact the affected facilities to arrange for STERIS to upgrade their Reliance 130 and 130L Cart Washer(s). For further information or if affected customers have any questions regarding the STERIS visit to their facility, they can contact STERIS Field Service Dispatch at 1800-333-8828
Quantity in Commerce 367
Distribution Worldwide Distribution -- USA (nationwide) including the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. and the countries of : Australia, South Korea, France, Italy, Lebanon, Russia, Saudi Arabia, Spain, UAE, United Kingdom and 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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