{ "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": "121499", "product_res_number": "Z-0134-2014", "event_date_initiated": "2013-08-26", "event_date_posted": "2013-11-01", "recall_status": "Terminated", "event_date_terminated": "2017-02-22", "res_event_number": "66112", "product_code": "DWF", "k_numbers": [ "K123370" ], "product_description": "Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, \n\nProduct Usage:\nEdwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.", "code_info": "Lot number 59388992 expiry 1/1/16", "firm_fei_number": "1713910", "recalling_firm": "Edwards Lifesciences, LLC", "address_1": "12050 Lone Peak Pkwy", "city": "Draper", "state": "UT", "postal_code": "84020-9414", "additional_info_contact": "Suzanne Carpenter\n801-565-6100", "reason_for_recall": "Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.", "root_cause_description": "Process control", "action": "Edwards sent an Urgent Field Safety Notice Product Recall letter dated August 26, 2013 to all affected customer, via Fed-Ex. The product is sold directly to hospitals and distributors. The distributors involved will communicate with their customers directly. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their entire inventory, quarantine and return the affected products. An acknowledgement form is included for completion to assist in the assessment of the inventory. For questions contact Edwards Customer Service at 800-424-3278.", "product_quantity": "80 units", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K250937", "K880779", "K881352", "K971023", "K955121", "K883412", "K140165", "K834134", "K152161", "K901074", "K880421", "K110980", "K171979", "K970914", "K802261", "K890024", "K020693", "K081820", "K033264", "K801397", "K990772", "K880180", "K840914", "K090878", "K023880", "K131269", "K854640", "K001371", "K010737", "K062597", "K844140", "K043179", "K801396", "K964195", "K832124", "K895352", "K030696", "K014303", "K930684", "K791832", "K896777", "K022272", "K052081", "K910021", "K972261", "K180979", "K801770", "K151523", "K991170", "K865079", "K905638", "K133445", "K971021", "K253671", "K993677", "K872043", "K964199", "K162500", "K831332", "K203067", "K801403", "K821316", "K884393", "K813037", "K872788", "K854487", "K081560", "K801392", "K881330", "K861310", "K842375", "K861096", "K092509", "K905312", 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