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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal

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  Class 2 Device Recall DeRoyal see related information
Date Initiated by Firm December 12, 2022
Date Posted January 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-0927-2023
Recall Event ID 91331
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Code Information a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023
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 a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
FDA Determined
Cause 2		 Packaging change control
Action DeRoyal sent an urgent recall notice to its consignees on 12/12/2022 by email and they followed with a letter sent overnight to the end user. The notice explained the problem and the hazard, and requested the following actions be taken: "1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com no later than January 15, 2023. 3) If you have questions regarding credit for the recall, please contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com. 4) PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) If you have further distributed these products, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer listing and we will contact them."
Quantity in Commerce 157 packs
Distribution US Nationwide distribution in the states of IL, MO.
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.
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