Class 2 Device Recall Reliance Endoscope Processing System (REPS)

• Date Initiated by Firm: August 29, 2013
• Date Posted: September 20, 2013
• Recall Status: Terminated on July 03, 2014
• Recall Number: Z-2263-2013
• Recall Event ID: 66247
• 510(K)Number: K040049 K102244 K110453
• Product Classification: Accessories, germicide, cleaning, for endoscopes - Product Code NZA
• Product: Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.
• Code Information: Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002
• FEI Number: 1527821
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: Mrs. Lindsey M. McGowan; 440-392-7519
• Manufacturer Reason for Recall: The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.
• FDA Determined Cause: Use error
• Action: Steris sent an "URGENT PRODUCT SAFETY NOTICE" dated September 5, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
• Quantity in Commerce: 266 units
• Distribution: Worldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain.
• 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 = NZA