Class 2 Device Recall Deroyal

• Date Initiated by Firm: May 30, 2023
• Date Posted: July 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2086-2023
• Recall Event ID: 92445
• 510(K)Number: K842648
• Product Classification: General surgery tray - Product Code LRO
• Product: Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292
• Code Information: a) REF '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers: 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383; b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers: 58714313; c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128 (unit), Lot Numbers: 58746278; d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers: 58745371; e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers: 58774885, 58774885; f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers: 58800174; g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers: 58762104; h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers: 58810330; i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit); ; Lot Numbers: 58698974; j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit); ; Lot Numbers: 58698907; k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit); ; Lot Numbers: 58777761; l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit); ; Lot Numbers: 58811834; m) REF '89-7540, GTIN 50749756741410 (cs), 00749756741415 (unit), Lot Numbers: 58737081; n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers: 58698042; o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers: 58736862; p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Numbers: 58823595; q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit); ; Lot Numbers: 58697963; r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers: 58789411; s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit); ; Lot Numbers: 58808416; t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit); ; Lot Numbers 58789260; u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit); ; Lot Numbers: 58738315 v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit); ; Lot Numbers: 58701598
• Recalling Firm/ Manufacturer: DeRoyal Industries Inc; 200 Debusk Ln; Powell TN 37849-4703
• For Additional Information Contact: Theresa Marsee; 865-632-6465
• Manufacturer Reason for Recall: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
• FDA Determined Cause: Process control
• Action: DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.
• Quantity in Commerce: 4225 packs
• Distribution: US Nationwide distribution.
• 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