{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "159686", "product_res_number": "Z-0199-2018", "event_date_initiated": "2017-10-16", "event_date_created": "2017-12-06", "recall_status": "Terminated", "event_date_terminated": "2020-08-21", "res_event_number": "78517", "product_code": "LRO", "k_numbers": [ "K842648" ], "product_description": "DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads:\na) Incision and Drainage Tray, REF 47-763.04\nb) Incision and Drainage Tray, REF 47-763.06\nc) Incision and Drainage Tray, REF 47-763.07\nd) Cricothyreotomy Ambulance Kit, REF 89-6752.01\ne) Incision and Drainage Tray, REF 89-6818.02\nf) Plastic Pack, REF 89-7212.04\ng) Plastic Pack, REF 89-7212.05\n\nProduct Usage:\nCustom surgical and procedural kits", "code_info": "a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132", "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": "865-938-7828", "reason_for_recall": "Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.", "root_cause_description": "Nonconforming Material/Component", "action": "DeRoyal sent an Urgent Recall Notice letter dated October 17, 2017, to the end-user level. The letter identified the affected product, problem and actions to be taken. Consignees were asked to return any product they held in stock to DeRoyal and to complete the Notice of Return Form indicating what they were returning. Credit will be issued. They were asked to complete and return the Notice of Return Form even if they no longer held any affected product. For questions call 865-362-4203.", "product_quantity": "5946 units", "distribution_pattern": "US Nationwide distribution in the states of GA, IN, FL, and PA", "openfda": { "k_number": [ "K881083", "K903336", "K971062", "K941846", "K925467", "K931758", "K962826", "K932652", "K950295", "K874760", "K873973", "K902888", "K910365", "K924468", "K854095", "K964921", "K931820", "K902887", "K953083", "K871873", "K882684", "K951149", "K890729", "K030721", "K936117", "K041080", "K854292", "K945831", "K902293", "K970187", "K935483", "K944044", "K935743", "K890098", "K964011", "K922648", "K931824", "K910368", "K950574", "K871437", "K945160", "K905459", "K961863", "K920292", "K935740", "K914174", "K934428", "K871434", "K933137", "K971061", "K932220", "K926269", "K923600", "K913136", "K932221", "K914935", "K952539", "K935858", "K914037", "K884093", "K880961", "K922133", "K871459", "K872448", "K951478", "K885090", "K934029", "K980137", "K914036", "K961683", "K934028", "K935741", "K892389", "K872011", 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