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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 September 18, 2023
Date Posted October 16, 2023
Recall Status1 Open3, 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 2
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 and Original Applicant = DEROYAL INDUSTRIES, INC.
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