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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 DeRoyalsee related information
Date Initiated by FirmMarch 03, 2022
Create DateApril 06, 2022
Recall Status1 Terminated 3 on September 15, 2022
Recall NumberZ-0879-2022
Recall Event ID 89737
510(K)NumberK842648 
Product Classification General surgery tray - Product Code LRO
ProductDeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Code Information SKU/Part Number 89-4990.06; UDI 00749756623599  Lot Numbers (Expiration Date): Lot 53334442 (exp 05/01/2021), Lot 53815781 (exp 06/01/2022), Lot 54685720 (exp 06/01/2022), Lot 55247529 (exp 03/01/2023), Lot 55967067 (exp 04/01/2023)
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactTheresa Marsee
865-362-6465
Manufacturer Reason
for Recall		A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
FDA Determined
Cause 2		Process control
ActionDeRoyal issued their recall on March 3, 2022 to the end user level by mailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the product and the notice of return form that was provided back to DeRoyal.
Quantity in Commerce780 kits
DistributionUS distribution to Florida, New Jersey, and Tennessee
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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