Class 2 Device Recall Quick Connects

• Date Initiated by Firm: March 20, 2003
• Date Posted: April 16, 2003
• Recall Status: Terminated on February 05, 2004
• Recall Number: Z-0724-03
• Recall Event ID: 25946
• 510(K)Number: k875280C
• Product Classification: Sterilizer, Chemical - Product Code MLR
• Product: 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
• Code Information: QFC1685 - Lots #3136314, #3136298, #3967981; QFC1683 - Lot #3136330; QFC1631 - Lot #4054870.
• Recalling Firm/ Manufacturer: Steris Corp; 5960 Heisley Rd; Mentor OH 44060
• Manufacturer Reason for Recall: The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.
• FDA Determined Cause: Other
• Action: The firm contacted their affected consignees by telephone and letter on 3/20/2003.
• Quantity in Commerce: 46
• Distribution: The devices were shipped to hospitals located in ME, NB, CA, IL, NJ, OH, IL, TX, MA, GA, MO, NC, and FL.
• 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.