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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 Kitssee related information
Date Initiated by FirmAugust 12, 2022
Create DateAugust 31, 2022
Recall Status1 Terminated 3 on September 20, 2024
Recall NumberZ-1668-2022
Recall Event ID 90749
510(K)NumberK842648 
Product Classification General surgery tray - Product Code LRO
ProductDeRoyal 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 ContactTheresa Marsee
865-938-7828
Manufacturer Reason
for Recall		Procedure packs contained a recalled product.
FDA Determined
Cause 2		Material/Component Contamination
ActionDeRoyal 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 Commerce1306 kits
DistributionUS Nationwide distribution in the states of OH and TN.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LRO
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