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U.S. Department of Health and Human Services

Class 2 Device Recall Reliance Endoscope Processing System (REPS)

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  Class 2 Device Recall Reliance Endoscope Processing System (REPS) see related information
Date Initiated by Firm August 29, 2013
Date Posting Updated September 20, 2013
Recall Status1 Terminated 3 on July 03, 2014
Recall Number Z-2263-2013
Recall Event ID 66247
510(K)Number K110453  K102244  K040049  
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
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 2
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 and Original Applicant = STERIS Corporation
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