Class 2 Device Recall DeRoyal

• Date Initiated by Firm: April 17, 2023
• Date Posted: June 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1691-2023
• Recall Event ID: 92299
• 510(K)Number: K842648
• Product Classification: General surgery tray - Product Code LRO
• Product: Sterile custom surgical procedure packs:; ; (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital;; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital;; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital;; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center;; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center;; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center;; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center;; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp;; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp;; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital;; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital;; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital;; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital;; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital;; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital;; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital;; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital;; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital;; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital;; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital;; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital;; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital;; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital;; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp;; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp;; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.
• Code Information: (1) 89-10507.02 - lot 58700464, exp 12/1/2024, GTIN pack-00749756362788, case-50749756362783; (2) 89-10508.02 - lot 58700430, exp 9/1/2026, GTIN pack-00749756362818, case-50749756362813; (3) 89-10509.02 - lot 58775010, exp 12/1/2024, GTIN pack-00749756362832, case-50749756362837; (4) 89-10517.04 - lot 58700579, exp 12/1/2024, GTIN pack-00749756363228, case-50749756363223; (5) 89-10526.04 - lot 58388765, exp 11/1/2024, GTIN pack-00749756363242, case-50749756363247; (6) 89-10530.04 - lot 58543121, exp 11/1/2024, GTIN pack-00749756364447, case-50749756364442; (7) 89-10532.04 - lot 58543905, exp 7/1/2024, GTIN pack-00749756363266, case-50749756363261; (8) 89-10534.02 - lots 58565821 and 58700561, exp 3/1/2024, GTIN pack-00749756363532, case-50749756363537; (9) 89-10544.03 - lot 58700000, exp 10/1/2024, GTIN pack-00749756366342, case-50749756366347; (10) 89-10545.02 - lot 58565830, exp 3/1/2024, GTIN pack-00749756363556, case-50749756363551; (11) 89-10552.02 - lot 58700667, 58700675, and 58724108, exp 12/1/2024, GTIN pack-00749756363549, case-50749756363544; (12) 89-10553.02 - lot 58544060, exp 11/1/2024, GTIN pack-00749756363624, case-50749756363629; (13) 89-10554.02 - lot 58544166, exp 12/1/2024, GTIN pack-00749756363440, case-50749756363445; (14) 89-10555.02 - lot 58589647 and 58724116, exp 12/1/2024, GTIN pack-00749756363648, case-50749756363643; (15) 89-10556.02 - lot 58589567, exp 12/1/2024, GTIN pack-00749756364287, case-50749756364282; (16) 89-10558.04 - lot 58542769, exp 11/1/2024, lot 58621694 and 58699993, exp 12/1/2024, GTIN pack-00749756364430, case-50749756364435; (17) 89-10560.03 - lot 58543201, 58554436, and 58700499, exp 9/1/2024, GTIN pack-00749756363778, case-50749756363773; (18) 89-10561.02 - lot 58542793, exp 11/1/2024, lot 58589591 and 58738016, exp 12/1/2024, GTIN pack-00749756363723, case-50749756363728; (19) 89-10562.02 - lot 58621820, exp 10/1/2024, GTIN pack-00749756364140, case-50749756364145; (20) 89-10564.02 - lot 58543083, exp 11/1/2024, and lot 58700501, exp 12/1/2024, GTIN pack-00749756363761, case-50749756363766; (21) 89-10569.02 - lot 58544182 exp 12/1/2024, GTIN pack-00749756363457, case-50749756363452; (22) 89-10570.02 - lot 58700739, exp 1/1/2024, and 58775036, exp 3/14/2024, GTIN pack-00749756363587, case-50749756363582; (23) 89-10574.02 - lot 58700641, exp 7/1/2024, GTIN pack-00749756364041, case-50749756364046; (24) 89-10575.02 - lot 58565848, exp 12/1/2023, GTIN pack-00749756366144, case-50749756366149; (25) 89-10576.03 - lot 58700704, exp 12/1/2024, GTIN pack-00749756364126, case-50749756364121; (26) 89-10580.03 - lot 58543454, exp 8/1/2024, GTIN pack-00749756366328, case-50749756366323.
• 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 custom procedure packs contain light handle covers that have been recalled by another firm.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued a letter dated 4/14/2023 to their sole consignee via email on 4/17/2023. The letter explained the reason for recall, the risk associated with the use of the device, and referred the customer to see the attached Affected Products Listing for detailed information, as the spreadsheet indicates the DeRoyal product numbers and lot numbers shipped to the customer. Additionally, the spreadsheet indicates the STERIS reference number, LB53, and lot numbers affected. The letter points out the recall is for the sterile STERIS light handle cover and the rest of the pack is not affected or impacted by the recall. The customer is to take the following actions: (1) Using the attached Affected Products Listing, identify the affected surgical pack numbers in your inventory and place it in quarantine to prevent further use. Place the label provided on each case and individual pack indicating that upon use, to remove and discard/destroy the STERIS Light Handle Covers that are contained within the pack; (2) Complete the Notice of Destruction Form indicating the number of affected products labeled and the customer will be given credit for the product discarded/destroyed. The completed form was to be returned to the recalling firm via FAX or email no later than 5/12/2023. (3) The customer is to complete and return the notice of destruction form even if they no longer have any product. (4) If the product has been further distributed, they are to notify their customers of the recall, which can be done by forwarding the recall notification onto the downstream customer or having the recalling firm notify their downstream customers. The recalling firm later discovered there were additional products to be included in the recall and notified their sole consignee via email on 5/16/2023 containing an updated spreadsheet of products.
• Quantity in Commerce: 1,391 cases (2,972 packs)
• Distribution: US Nationwide distribution in the state of VA.
• 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 and Original Applicant = DEROYAL INDUSTRIES, INC.