{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198983", "product_res_number": "Z-1318-2023", "event_date_initiated": "2023-02-10", "event_date_posted": "2023-04-01", "recall_status": "Open, Classified", "res_event_number": "91841", "product_code": "BTR", "k_numbers": [ "K871204" ], "product_description": "COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D.\n\nThe Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for\nairway management by oral/nasal intubation of the trachea for anesthesia\nor other short-term procedures.", "code_info": "Product Number: 86051\nUDI-DI (GTIN) Code: 60884522000241\nLot Numbers:\n22G0343JZX\n22G0344JZX", "firm_fei_number": "2936999", "recalling_firm": "Covidien", "address_1": "6135 Gunbarrel Ave", "city": "Boulder", "state": "CO", "postal_code": "80301-3214", "additional_info_contact": "Technical Support\n800-255-6774 Ext. 4", "reason_for_recall": "Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.", "root_cause_description": "Process control", "action": "On 02/10/2023, Medtronic issued an \"Urgent Medical Device Recall\" letter via UPS 2 day delivery to customers informing them of potential cuff leaks from the device inflation system in Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed.\n\nCustomer are instructed to:\n1. Quarantine all unused product from the affected lots of Shiley\" Lo-Pro Oral/Nasal Tracheal Tube Cuffed. See attachment A for guidance on identifying potentially affected devices.\n2. Return all unused product from the affected lots in their inventory to Medtronic as described on the Customer Confirmation Form.\n3. Complete the enclosed Customer Acknowledgment Form even if they do not have unused inventory.\n4. Pass on the notice to all those who need to be aware within their organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.\n\nAdditional Information for Patient Management:\nAs stated in the Instructions for Use that accompanies each device, each tube s cuff should be tested by inflation prior to use. Use of a device with this potential manufacturing assembly error may result in a delay to treatment while an alternate device is obtained.\nThere are no additional patient management recommendations that should be employed for patients where potentially affected devices are currently in use or were used. These patients should be monitored in accordance with your medical facility s critical care protocols. Clinical staff should appropriately assess and manage patients for any adverse clinical outcomes.\n\nFor questions or further assistance, contact a Medtronic Representative or Customer Service at 800-962-9888.", "product_quantity": "12,310 devices", "distribution_pattern": "U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV\n\nO.U.S.: Canada", "openfda": { "k_number": [ "K945455", "K843714", "K941969", "K080821", "K211543", "K870470", "K925506", "K930150", "K932647", "K242495", "K791046", "K840943", "K802505", "K181880", "K841872", "K822082", "K833197", "K833831", "K852493", "K861462", "K942628", "K223130", "K830631", "K111401", "K961840", "K870387", "K895132", "K871632", "K042683", "K934117", "K951697", "K951768", "K131254", "K871204", "K170234", "K823757", "K932280", "K113333", "K915277", "K051993", "K110269", "K213028", "K821027", "K790927", "K940041", "K990619", "K930741", "K243579", "K945745", "K091591", "K192120", 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