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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 September 01, 2011
Recall Status1 Terminated on March 19, 2013
Recall Number Z-3124-2011
Recall Event ID 59752
Premarket Notification
510(K) Numbers
K090036  K101409  K102462 
Product Classification Sterilizer, Chemical - Product Code MLR
Product SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: 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 # P6500, S/N: 400001 through 405005
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060
Manufacturer Reason
for Recall
STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action STERIS sent an "Urgent Field Correction Notice" letter dated July 2011 to all affected customers. The letter describes the product, problem and actions to be taken. The letter states that STERIS Service Representative will contact customers to schedule the repair of the recalled product. For further information or questions contact STERIS Field Service Dispact at 1-800-333-8828.
Quantity in Commerce 2,235 units
Distribution Worldwide Distribution - USA (nationwide) and the country of Bahrain.
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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