Class 3 Device Recall Reliance EPS Endoscope Processing System

• Date Initiated by Firm: July 02, 2010
• Date Posted: December 28, 2010
• Recall Status: Terminated on September 27, 2012
• Recall Number: Z-0823-2011
• Recall Event ID: 56245
• 510(K)Number: K040049
• Product Classification: Sterilizer, chemical - Product Code MLR
• Product: Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada. Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices.
• Code Information: Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060
• For Additional Information Contact: 440-392-7601
• Manufacturer Reason for Recall: Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced.
• FDA Determined Cause: Other
• Action: Steris issued an "Urgent Field Correction Notice" dated July 2, 2010 to each affected US consignee, notifying them of the issue and affected device. Steris Field Service Representatives and Dealers will contact each affected customer to schedule a service visit to install system upgrades. In the event of an interrupted cycle prior to the upgrade, consignees were instructed that the load should be handled in accordance with the Reliance EPS Operators Manual. Steris can be contacted at 440-392-7043.
• Quantity in Commerce: 936
• Distribution: Worldwide distribution: USA, including states of AK, AL, AZ, CA, CO, DE, FL, ID, IL, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, SC, VA, WA, WI, and WY, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom.
• 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.

• 510(K) Database: 510(K)s with Product Code = MLR