{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 14 } }, "results": [ { "cfres_id": "187004", "product_res_number": "Z-1929-2021", "event_date_initiated": "2021-03-16", "event_date_created": "2021-06-23", "recall_status": "Open, Classified", "res_event_number": "87787", "product_code": "FMK", "product_description": "FREESTYLE LANCETS 28G 100CT\nItem Number:2975670", "code_info": "NDC/UPC: 699073130013 All lots numbers shipped from 2/23/201 to 3/10/2021", "firm_fei_number": "3004008697", "recalling_firm": "Cardinal Health Inc.", "address_1": "7000 Cardinal Pl", "city": "Dublin", "state": "OH", "postal_code": "43017-1091", "reason_for_recall": "Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.", "root_cause_description": "Environmental control", "action": "On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements.\n\nActions Required\n1.\tINSPECT your inventory for the affected product.\n2.\tSEGREGATE and QUARANTINE all affected product.\n3.\tRETURN the enclosed acknowledgment form via fax to 1-817-868-5362 or email to rxrecalls@inmar.com, even if you do not have any product on hand.\n4.\tCONTACT Inmar to arrange for return and credit of any affected product: 1-855-696-2074 (9:00 AM to 5:00 PM, Monday thru Friday)", "product_quantity": "377 boxes of 100 lancets", "distribution_pattern": "US Nationwide distribution in the states of FL, GA, SC.", "openfda": { "k_number": [ "K101417", "K041665", "K231124", "K923302", "K830010", "K252490", 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