Class 2 Device Recall DeRoyal (R) CYSTO TRAY

• Date Initiated by Firm: August 11, 2016
• Date Posted: August 26, 2016
• Recall Status: Terminated on June 13, 2017
• Recall Number: Z-2679-2016
• Recall Event ID: 74927
• 510(K)Number: K842648
• Product Classification: General surgery tray - Product Code LRO
• Product: DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
• Code Information: Lot Number 40004006
• Recalling Firm/ Manufacturer: DeRoyal Industries Inc; 200 Debusk Ln; Powell TN 37849-4703
• For Additional Information Contact: Theresa Marsee; 865-362-6465
• Manufacturer Reason for Recall: The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
• FDA Determined Cause: Nonconforming Material/Component
• Action: DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.
• Quantity in Commerce: 24 units
• Distribution: Distributed in LA and TN.
• 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 = LRO