{ "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": "35726", "product_res_number": "Z-0310-05", "event_date_initiated": "2004-10-29", "event_date_posted": "2004-12-15", "recall_status": "Terminated", "event_date_terminated": "2012-07-07", "res_event_number": "30357", "product_code": "ETN", "k_numbers": [ "K925640" ], "product_description": "Brand name:\t\t\nNIM EMG Endotracheal Tube \t\t REF 82-29106, 82-29107, 82-29108\n\t \nNIM EMG Reinforced Endotracheal Tube \t REF 82-29306, 82-29307, 82-29308\n\t \n[All products are packaged one unit per box.]", "code_info": "Product Code:\t77 ETN  Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr N", "city": "Jacksonville", "state": "FL", "postal_code": "32216-6218", "reason_for_recall": "The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.", "root_cause_description": "Other", "product_quantity": "22569 EMG Tubes", "distribution_pattern": "Distributed nationwide and worldwide.\n\nto countries in the five continents with the highest populations.", "openfda": { "k_number": [ "K982595", "K992869", "K032083", "K111597", "K111671", "K100992", "K092292", "K230320", "K934733", "K031003", "K923056", "K905035", "K150005", "K152769", "K050162", "K110138", "K000507", "K031510", "K083242", "K090838", "K880720", "K905045", "K945799", "K112435", "K103128", "K061365", "K894930", "K112718", "K112686", "K874018", "K242852", "K964869", "K014165", "K063560", "K980148", "K091874", "K040543", "K063305", "K895676", "K093373", "K212355", "K933491", "K110712", "K081742", "K110696", "K881757", "K121931", "K251672", "K133348", "K870272", "K062549", "K010213", "K200886", "K092729", "K843226", "K102862", "K781569", "K021595", "K003745", "K020955", "K912508", "K152505", "K110989", "K071349", "K231580", 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