QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. The QFC1631 is for Fujinon 450/485 Series Video Gastroscopes; The QFC1683 is for Fujinon EC-450LP Colonoscopes; The QFC1685 is for Fujinon 450/485 Series Video Colonoscopes with Water Jet;
- Company
- Steris Corp
- Recall Initiated
- March 20, 2003
- Posted
- April 16, 2003
- Terminated
- February 5, 2004
- Recall Number
- Z-0724-03
- Quantity
- 46
- Firm Location
- Mentor, OH
Reason for Recall
The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.
Distribution
The devices were shipped to hospitals located in ME, NB, CA, IL, NJ, OH, IL, TX, MA, GA, MO, NC, and FL.
Lot / Code Info
QFC1685 - Lots #3136314, #3136298, #3967981; QFC1683 - Lot #3136330; QFC1631 - Lot #4054870.
Root Cause
Other
Action Taken
The firm contacted their affected consignees by telephone and letter on 3/20/2003.
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