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Class 2 Device Recall Reliance Endoscope Processing System (REPS) |
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Date Initiated by Firm |
August 29, 2013 |
Date Posted |
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
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Product Classification |
Accessories, germicide, cleaning, for endoscopes - Product Code NZA
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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
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For Additional Information Contact |
Mrs. Lindsey M. McGowan 440-392-7519
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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.
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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
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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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510(K) Database |
510(K)s with Product Code = NZA and Original Applicant = STERIS Corporation
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