{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192326", "product_res_number": "Z-0879-2022", "event_date_initiated": "2022-03-03", "event_date_created": "2022-04-06", "recall_status": "Terminated", "event_date_terminated": "2022-09-15", "res_event_number": "89737", "product_code": "LRO", "k_numbers": [ "K842648" ], "product_description": "DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.", "code_info": "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)", "firm_fei_number": "1043214", "recalling_firm": "DeRoyal Industries Inc", "address_1": "200 Debusk Ln", "city": "Powell", "state": "TN", "postal_code": "37849-4703", "additional_info_contact": "Theresa Marsee\n865-362-6465", "reason_for_recall": "A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.", "root_cause_description": "Process control", "action": "DeRoyal 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. 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