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U.S. Department of Health and Human Services

Class 2 Device Recall The SYSTEM 1E Liquid Sterilant Processing System.

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  Class 2 Device Recall The SYSTEM 1E Liquid Sterilant Processing System. see related information
Date Initiated by Firm August 01, 2012
Date Posted September 07, 2012
Recall Status1 Terminated 3 on June 06, 2014
Recall Number Z-2335-2012
Recall Event ID 62895
510(K)Number K090036  K101409  K102462  
Product Classification Sterilant Medical Devices - Product Code MED
Product The SYSTEM 1E Liquid Sterilant Processing System.

The SYSTEM 1E Liquid 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 400000 through 406294
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Lindsey M. McGowan
440-392-7519
Manufacturer Reason
for Recall		 The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action STERIS sent a Urgent Voluntary Field Correction Notice letter dated August 1, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS has received no reports of injuries associated with the disconnection of a SYSTEM IE water hose. STERIS Corporation will instill new hoses and connections on your SYSTEM IE Liquid Chemical Sterilant Processing System. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.
Quantity in Commerce 6,051 units
Distribution Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
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
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