{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "156096", "product_res_number": "Z-0590-2018", "event_date_initiated": "2017-06-02", "event_date_created": "2018-02-12", "recall_status": "Open, Classified", "res_event_number": "77469", "product_code": "DWJ", "k_numbers": [ "K142702" ], "product_description": "Arctic Sun ArcticGel Pads - Medium, Product Code 317-07", "code_info": "Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.", "firm_fei_number": "1018233", "recalling_firm": "C.R. Bard, Inc.", "address_1": "8195 Industrial Blvd NE", "city": "Covington", "state": "GA", "postal_code": "30014-1497", "additional_info_contact": "800-526-4455", "reason_for_recall": "Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.", "root_cause_description": "Labeling mix-ups", "action": "Customers were notified on approximately 06/02/2017 via FedEx with delivery confirmation and per the individual country's delivery system. Instructions included to examine inventory and identify any product subject to the recall and notify customers if product was further distributed. 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