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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 FirmAugust 01, 2012
Date PostedSeptember 07, 2012
Recall Status1 Terminated 3 on June 06, 2014
Recall NumberZ-2335-2012
Recall Event ID 62895
510(K)NumberK090036 K101409 K102462 
Product Classification Sterilant Medical Devices - Product Code MED
ProductThe 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
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactLindsey 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
ActionSTERIS 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 Commerce6,051 units
DistributionWorldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MED
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