Class 2 Device Recall QPC1680 Quick Connect

• Date Initiated by Firm: March 15, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 18, 2004
• Recall Number: Z-0765-04
• Recall Event ID: 28569
• 510(K)Number: K875280
• Product Classification: Sterilant, Medical Devices - Product Code MED
• Product: QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680
• Code Information: Lots #2925196, #2911782, #2925238.
• Recalling Firm/ Manufacturer: Steris Corp; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: 440-392-7019
• Manufacturer Reason for Recall: A defective port adapter may affect the sterilization process of the attached endoscope.
• FDA Determined Cause: Process control
• Action: The firm contacted the consignees by letter and in person.
• Quantity in Commerce: 40 units
• Distribution: The product was shipped to domestic consignees in LA, NC, OH, CT, VA, CA, ME, MD, IL, PA, SC, WY, ND, NY, OK, TX. Foreign distribution involves: Canada, Italy, and Germany.
• 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.

• 510(K) Database: 510(K)s with Product Code = MED