Class 2 Device Recall DeRoyal

• Date Initiated by Firm: September 18, 2023
• Date Posted: October 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0116-2024
• Recall Event ID: 93078
• 510(K)Number: K842648
• Product Classification: General surgery tray - Product Code LRO
• Product: DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
• Code Information: UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027
• 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: DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.
• FDA Determined Cause: Nonconforming Material/Component
• Action: DeRoyal issued an URGENT RECALL NOTICE to its sole consignee on 09/18/2023 by email. The notice explained the problem, the risk to health, and requested the return of the product. Distributors were requested to notify their customers.
• Quantity in Commerce: 32 kits
• Distribution: Pennsylvania
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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