{ "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": "159384", "product_res_number": "Z-0169-2018", "event_date_initiated": "2017-09-25", "event_date_created": "2017-11-21", "recall_status": "Open, Classified", "res_event_number": "78377", "product_code": "LRO", "product_description": "Regard Custom Surgical Pack\n\nPacks contain surgical instruments and accessories intended for use during a surgical procedure.", "code_info": "Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019", "firm_fei_number": "3004513970", "recalling_firm": "Resource Optimization & Innovation Llc", "address_1": "2909 N Neergard Ave", "city": "Springfield", "state": "MO", "postal_code": "65803-6317", "additional_info_contact": "417-820-2793", "reason_for_recall": "Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a \"ChloraPrep One-Step\" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct \"ChloraPrep With Tint\" label.\n\nThe recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.", "root_cause_description": "Error in labeling", "action": "Customer was notified of the recall via email on September 25, 2017. \n\nInstructions included identify and quarantine any affected products, notify ROi by completing and returning the completed notification form, coordinating the issuance of supplemental labeling which will instruct the end user to remove and discard the recalled ChloraPrep at the time of use. For further questions, please call (417) 820-2793", "product_quantity": "51 units", "distribution_pattern": "Distributed domestically to Texas.", "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", "K883250", 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