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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 System see related information
Date Initiated by Firm August 11, 2011
Date Posted September 01, 2011
Recall Status1 Terminated 3 on March 19, 2013
Recall Number Z-3124-2011
Recall Event ID 59752
510(K)Number 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 OH 44060
For Additional Information Contact
440-392-7601
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
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 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 = MLR and Original Applicant = STERIS Corporation
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