{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "131945", "product_res_number": "Z-0867-2015", "event_date_initiated": "2014-11-17", "event_date_posted": "2014-12-24", "recall_status": "Terminated", "event_date_terminated": "2015-08-18", "res_event_number": "69910", "product_code": "BTR", "k_numbers": [ "K131254" ], "product_description": "KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC.\n\nUsed for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.", "code_info": "Product Code: 13222, Lot numbers: AA3213, AA3213V03, AA3227, AA3227V01, AA3239, AA3239V01, AA3245, AA3245V02, AA3249, AA3249V01, AA3249V03, AA3253V02, AA3269V01, AA3274, AA3274V01, AA3274V04, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4062V03, AA4062V04, AA4083, AA4083V02, AA4097, AA4097V02, AA4097V04, AA4104V01, AA4104V02, AA4111, AA4111V01, AA4111V02, AA4113V01, AA4125V03, AA4134V01, AA4146V01, AA4146V04, AA4155V03, AA4167V01, AA4170V01, AA4174V01, AA4217V01 & AA4226V01.", "firm_fei_number": "3011157493", "recalling_firm": "Halyard Health", "address_1": "1400 Holcomb Bridge Rd", "city": "Roswell", "state": "GA", "postal_code": "30076-2190", "additional_info_contact": "Thomas Kozma, PhD\n770-587-8393", "reason_for_recall": "The cuff inflation line may detach from the endotracheal tube during use.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, Halyard Health, sent an \"URGENT: VOLUNTARY PRODUCT RECALL\" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product.\n\nIf you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.", "product_quantity": "400 cases (10 tubes per case)", "distribution_pattern": "Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, 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