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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 Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systemsee related information
Date Initiated by FirmNovember 21, 2013
Date PostedDecember 31, 2013
Recall Status1 Terminated 3 on June 16, 2014
Recall NumberZ-0616-2014
Recall Event ID 67002
510(K)NumberK090036 K101409 K102462 K113520 K131078 
Product Classification Sterilant, medical devices - Product Code MLR
ProductSYSTEM 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 OH 44060-1834
For Additional Information ContactMrs. 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		Device Design
ActionSTERIS 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 Commerce6,028 units
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = MLR
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