Class 2 Device Recall Steris Quick Connect (tethered)

• Date Initiated by Firm: March 07, 2003
• Date Posted: February 06, 2003
• Recall Status: Terminated on February 05, 2004
• Recall Number: Z-0547-03
• Recall Event ID: 25374
• 510(K)Number: k875280
• Product Classification: Sterilizer, Chemical - Product Code MLR
• Product: C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.
• Code Information: Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473).
• Recalling Firm/ Manufacturer: Steris Corp; 5960 Heisley Rd; Mentor OH 44060
• Manufacturer Reason for Recall: The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.
• FDA Determined Cause: Other
• Action: On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced.
• Quantity in Commerce: 1,140 units
• Distribution: Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.
• 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 = MLR and Original Applicant = STERIS C/O MEDICAL DEVICE CONSULTANTS, INC.