Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
C1160 Universal Flexible Processing Tray		see related information
Date Posted August 05, 2008
Recall Number Z-1190-2008
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, Ohio 44060-1834
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Holly Wright Lee
440-392-7019
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.
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.
 
-
-