Class 2 Device Recall Steris

• Date Initiated by Firm: December 04, 2015
• Create Date: March 16, 2016
• Recall Status: Terminated on August 26, 2016
• Recall Number: Z-1180-2016
• Recall Event ID: 73009
• 510(K)Number: K131078
• Product Classification: Sterilant, medical devices - Product Code MED
• Product: Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
• Code Information: All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: Ms. Kathryn E. Cadorette; 440-392-7231
• Manufacturer Reason for Recall: The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.
• Quantity in Commerce: 809 units
• Distribution: Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
• 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