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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 Recall
C1160 Universal Flexible Processing Tray
see related information
Date Posted August 05, 2008
Recall Status1 Open
Recall Number Z-1190-2008
Recall Event ID 46753
Premarket Notification
510(K) Number
Product Classification Sterilant, Medical Devices - 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/
Steris Corp
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Holly Wright Lee
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
DESIGN: 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 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 = CIVCO MEDICAL INSTRUMENTS CO., INC.