{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "188476", "product_res_number": "Z-2319-2021", "event_date_initiated": "2021-07-16", "event_date_created": "2021-08-19", "recall_status": "Completed", "res_event_number": "88353", "product_code": "BTR", "k_numbers": [ "K780900" ], "product_description": "RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers:\na) 170050\nb) 170055\nc) 170060\nd) 170065\ne) 170070 \nf) 170075 \ng) 170080\nh) 170085 \ni) 170090\nj) 170095", "code_info": "a) 170050, Lot Numbers: KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21C0488\nb) 170055, Lot Numbers: KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21A0383, KME21A1901, KME21B2682, KME21C2708\nc) 170060, Lot Numbers: KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293\nd) 170065, Lot Numbers: KME20K0938, \tKME20K2623, KME20L0487, KME20L1705, KME20M1578, KME20M1751, KME20M2709, KME21A0385, KME21A1812, KME21B1670, KME21B2499, KME21B2500, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043\ne) 170070, Lot Numbers: KME20K2544, KME20L0053, KME20L0055, KME20L0942, KME20L2372, KME20M0381, KME20M0665, KME20M1103, KME20M1754, KME20M1755, KME21A0893, KME21A2264, KME21B1074, KME21B1075, KME21C0463, KME21C0464, KME21C1027, KME21C1422, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043\nf) 170075, Lot Numbers: KME20K1352, KME20L1132, KME20M0033, KME20M0382, KME20M1149, KME20M1225, KME20M1227, KME20M1537, KME20M2881, KME20M2882, KME21A0824, KME21A1161, KME21A1813, KME21B0813, KME21C0212, KME21C0213, KME21C1594, KME21C1895, KME21C2855, KME21C3294, KME21C3295\ng) 170080, Lot Numbers: KME20L0396, KME20L1278, KME20L1279, KME20L2830, KME20M0847\t, KME21A0386, KME21A2800, KME21A2801, KME21B1245, KME21B1752, KME21B2156, KME21C0465, KME21C0533, KME21C2826\nh) 170085, Lot Numbers: KME20L0398, KME20L2376, KME20M3247, KME21A1894, KME21C0298, KME21C2385\ni) 170090, Lot Numbers: KME20L0625\nj) 170095, Lot Numbers: KME20M0384, KME21B0407", "firm_fei_number": "3007134520", "recalling_firm": "Teleflex Medical Europe Ltd", "address_1": "Ida Business Park", "city": "Athlone", "country": "Ireland", "additional_info_contact": "3530877519577", "reason_for_recall": "The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.", "root_cause_description": "Process control", "action": "The firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers.", "product_quantity": "32410 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K862238", "K940041", "K844746", "K925506", "K032112", "K960795", "K241451", "K952013", "K821180", "K141939", "K172208", "K161813", "K160694", "K111406", "K000045", "K860901", "K023964", "K880487", "K080821", "K832629", "K830631", "K823757", "K862950", "K930114", "K853502", "K932280", "K190878", "K093135", "K861461", "K190274", "K821243", "K790312", "K971759", "K812943", "K945745", "K925508", "K200761", "K965132", "K925505", "K013321", "K043205", "K791046", "K860105", "K233341", "K192120", "K861454", "K871632", "K945816", "K090777", "K110269", "K170234", "K041311", "K052233", "K213028", "K090352", "K082038", "K844296", "K842464", "K915799", "K110962", "K954585", "K910463", "K760998", "K781808", "K874679", "K081086", "K872366", "K811937", "K080339", "K896181", "K790927", "K080105", "K852493", "K830352", "K082520", 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