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U.S. Department of Health and Human Services

Class 2 Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing System

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 Class 2 Recall
SYSTEM 1E Liquid Chemical Sterilant Processing System
see related information
Date Posted December 31, 2013
Recall Status1 Terminated on June 16, 2014
Recall Number Z-0616-2014
Recall Event ID 67002
Premarket Notification
510(K) Numbers
K090036  K101409  K102462  K113520  K131078 
Product Classification Sterilizer, Chemical - Product Code MLR
Product SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Code Information Model #6500 & 7500
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Mrs. Lindsey M. McGowan
440-392-7519
Manufacturer Reason
for Recall
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
FDA Determined
Cause 2
DESIGN: Device Design
Action STERIS sent an Urgent Voluntary Field Correction Notice dated November 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a STERIS Field Service Representative would contact their facility to schedule installation of the new hardware and updated software on their SYSTEM IE Liquid Chemical Sterilant Processing System(s). Customers were instructed that they may continue to operate the SYSTEM IE processor prior to the completion of the update. Customers with questions were instructed to contact STERIS Field Service Dispatch at 1-800-333-8828. For questions regarding this recall call 440-392-7519.
Quantity in Commerce 6,028 units
Distribution Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = STERIS CORPORATION
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