{ "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": "166482", "product_res_number": "Z-0075-2019", "event_date_initiated": "2018-07-06", "event_date_created": "2018-10-05", "recall_status": "Terminated", "event_date_terminated": "2019-04-30", "res_event_number": "80635", "product_code": "CAT", "product_description": "smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. \n\nProduct Usage:\nFor the administration of nasal oxygen and humidity to patients.", "code_info": "Lot number 1705171A", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "reason_for_recall": "\"Manufactured\" and \"Use By\" labels are transposed incorrectly suggesting the product expires before it was manufactured.", "root_cause_description": "Labeling design", "action": "The recalling firm issued an Urgent Medical Device Recall letters dated July 6, 2018 via UPS tracked hard-copy mailing The letter identified the affected product, problem and actions to be taken. Customers were requested to return affected products using the enclosed shipping label. For questions email Stericycle at SmithsMedical7434@stericycle.com.", "product_quantity": "850 devices", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. 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