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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm see related information
Date Initiated by Firm December 07, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on May 13, 2014
Recall Number Z-0869-2012
Recall Event ID 60742
510(K)Number K090036  K102462  
Product Classification Sterilant, medical devices - Product Code MED
Product STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011.

The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Code Information MED. Serial Numbers: 400000 through 405499 are subject to correction.
Recalling Firm/
Steris Corporation Hopkins Facility
6515 Hopkins Rd
Mentor OH 44060-4307
For Additional Information Contact Rosemary Niewolak
Manufacturer Reason
for Recall
Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteriae may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which
FDA Determined
Cause 2
Software design
Action The firm, STERIS Corp. prepared an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated December 8, 2011. The firm intends to send the letter to its customers upon STERIS' receipt of 510(k) clearance from FDA. The letter includes a description of the Product-SYSTEM ¿¿ Liquid Chemical Sterilant Processing System, problem and actions taken. The customers were instructed to in case of an incomplete or cancelled cycle, reprocess devices in the cycle following the directions in the Operator manual. The letter also states that STERIS Corporation will install updated software on the affected system, and will be providing the customers with a new Operator Manual reflecting the revised wording resulting from the installation of the new software. For further information or if they have any questions regarding the firms visit to their facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, contact Director Low Temperature Sterilization, at 440-392-7455.
Quantity in Commerce 3,882 units were distributed
Distribution Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
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 = MED and Original Applicant = STERIS Corporation