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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 Recall
The SYSTEM 1E Liquid Sterilant Processing System.
see related information
Date Posted September 07, 2012
Recall Status1 Terminated on June 06, 2014
Recall Number Z-2335-2012
Recall Event ID 62895
Premarket Notification
510(K) Numbers
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, Ohio 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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 = MED and Original Applicant = STERIS Corporation
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