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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Sterile Custom Kits

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  Class 2 Device Recall DeRoyal Sterile Custom Kits see related information
Date Initiated by Firm August 12, 2022
Create Date August 31, 2022
Recall Status1 Open3, Classified
Recall Number Z-1668-2022
Recall Event ID 90749
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Code Information NS CVR PREP PACK /89-6817.09; Lots 56391514 (exp 08/01/2023), 56926777 (exp 08/01/2023), 57103035 (exp. 08/01/2023); UDI-DI (GTIN): 00749756730938 NON-STERILE IR ADMISSION KIT / 89-8762.05; Lot 57104020 (exp 07/01/2023); UDI-DI (GTIN): 00749756883627
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Theresa Marsee
865-938-7828
Manufacturer Reason
for Recall		 Procedure packs contained a recalled product.
FDA Determined
Cause 2		 Material/Component Contamination
Action DeRoyal issued their recall notification on 08/12/2022 to the end user level by emailing recall letters to affected consignees. The consignees are asked to identify the affected products and return any affected product and to complete the return form back to DeRoyal.
Quantity in Commerce 1306 kits
Distribution US Nationwide distribution in the states of OH and TN.
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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