{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "160713", "product_res_number": "Z-0334-2018", "event_date_initiated": "2017-12-19", "event_date_created": "2018-01-12", "recall_status": "Terminated", "event_date_terminated": "2018-06-21", "res_event_number": "78843", "product_code": "LRO", "k_numbers": [ "K842648" ], "product_description": "DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows:\n(a) Shoulder Arthroscopy Pack 89-8686.01\n(b) Shoulder Arthroscopy Pack 89-8686.02\n(c) Knee Arthro Pack 89-8687.01\n(d) Knee Arthro Pack 89-8687.02\n\nProduct Usage: general surgical", "code_info": "(a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122", "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": "DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, DeRoyal, sent an \"URGENT! RECALL NOTICE\" letter dated 12/19/2017 to its Consignees overnight. The letter describe the product, problem and actions to be taken. The Consignees were instructed to identify affected product; place in quarantine to prevent further use, and complete and return the Affected Products Listing form to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 1/15/2018, even if you no longer have any inventory. \n\nIf you have questions or need assistance with the recall, please email jmarsh@deroyal.com or call by phone 865-362-4203 or email us at recalls@deroyal.com.", "product_quantity": "226 kits", "distribution_pattern": "Distributed to states of: CA and MO.", "openfda": { "k_number": [ "K930270", "K964011", "K041080", "K963715", "K970187", "K935858", "K931824", "K930700", "K963443", "K935686", "K920292", "K933137", "K023276", "K925214", "K936117", "K961863", "K885090", "K873973", "K895202", "K934028", "K871322", "K934428", "K952539", "K880961", "K920267", "K884093", "K914935", "K854292", "K931673", "K212258", "K945481", "K925216", "K931760", "K910365", "K874439", "K902888", "K871437", "K935740", 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