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.
|