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U.S. Department of Health and Human Services

Class 2 Device Recall C1160 Universal Flexible Processing Tray

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  Class 2 Device Recall C1160 Universal Flexible Processing Tray see related information
Date Initiated by Firm February 19, 2008
Date Posted August 05, 2008
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1190-2008
Recall Event ID 46753
510(K)Number K875280C  
Product Classification tray for endoscope sterilizer - Product Code MED
Product Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
Code Information All codes
Recalling Firm/
Manufacturer		 Steris Corp
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Holly Wright Lee
440-392-7019
Manufacturer Reason
for Recall		 Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly.
FDA Determined
Cause 2		 Device Design
Action Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.
Quantity in Commerce 28,766 units
Distribution Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan.
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.
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