{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73204", "product_res_number": "Z-0174-2009", "event_date_initiated": "2008-07-18", "event_date_posted": "2008-10-27", "recall_status": "Terminated", "event_date_terminated": "2009-08-24", "res_event_number": "49360", "product_code": "FMK", "product_description": "Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. \nLancing Device intended to be used by diabetes patients that require a drop of capillary blood for testing.", "code_info": "Lot Numbers: M057030, and M057022; Unit numbers: L339011, L339011, L339011, and L339011,", "firm_fei_number": "3011617315", "recalling_firm": "Facet Technologies", "address_1": "101 Liberty Industrial Pkwy", "city": "McDonough", "state": "GA", "postal_code": "30253-7556", "additional_info_contact": "Scott Haygood\n770-898-3223", "reason_for_recall": "The Alternate Site Cap was not included in the package as indicated on the labeling.", "root_cause_description": "Error in labeling", "action": "The consignees were notified by letter on/about 7/18/2008. The Return Material Authorization number was communicated to the customer. They were asked to place the items on hold and Can Am will obtain any quantities. The Returned Product Mechanics Process will: Inventory will be sent back to Facet in two stages, Inventory on hand at Cimetra will be sent back to Facet, Inventory received back from customers will be sent back to Facet in one shipment 30-60 days after notice. Inventory received back after this second shipment will be destroyed.", "product_quantity": "2976 units", "distribution_pattern": "Nationwide--GA and FL.", "openfda": { "k_number": [ "K260191", "K223826", "K894427", "K221368", "K833812", "K920562", "K024170", "K101145", "K931828", "K944948", "K822209", "K222084", "K251694", "K923302", "K232509", "K823760", "K192666", "K222376", "K883420", "K810075", "K220917", "K883957", "K210745", "K870017", "K252490", "K894474", "K221778", "K942548", "K931258", "K932785", "K222090", "K223900", "K223370", "K113332", "K222111", "K172712", "K221783", "K130132", "K863621", "K222303", "K222408", "K241750", "K242627", "K242316", "K902430", "K041665", "K850150", "K222168", "K820333", "K244036", "K220849", "K830001", "K193009", "K232488", "K221604", "K231124", "K223201", "K233796", "K833816", "K220372", "K855203", "K902416", "K220370", "K223208", "K883968", "K865016", "K241627", "K861265", "K833344", "K880869", "K861243", "K113513", "K221126", "K253605", 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"878.4850", "device_class": "2" } } ] }