{ "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": "149196", "product_res_number": "Z-0044-2017", "event_date_initiated": "2016-08-26", "event_date_posted": "2016-10-18", "recall_status": "Terminated", "event_date_terminated": "2017-03-21", "res_event_number": "75053", "product_code": "JOH", "k_numbers": [ "K964056" ], "product_description": "Willy Rusch GmbH Tracheostomy Tube Set\n\nCannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.", "code_info": "Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491", "firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "3015 Carrington Mill Blvd", "city": "Morrisville", "state": "NC", "postal_code": "27560-5437", "additional_info_contact": "Alice K. Harper\n610-378-0131", "reason_for_recall": "The connector may disconnect from the tracheostomy tube during use.", "root_cause_description": "Use error", "action": "Teleflex sent an Urgent Field Safety Notice dated August 26, 2016, to all affected consignees. The letter requested that consignees cease use and distribution of stock, quarantine immediately, and return the product. Also, the letter requested a sub-recall if the product had been further distributed. The letter included an Acknowledgement Form which is to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service.\nFor questions regarding this recall call 610-378-0131.", "product_quantity": "1095 units", "distribution_pattern": "Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.", "openfda": { "device_name": "Tube Tracheostomy And Tube Cuff", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5800", "device_class": "2", "k_number": [ "K962173", "K962078", "K812302", "K925020", "K122531", "K031057", "K972385", "K894614", "K897059", "K945874", "K011210", "K133528", "K043160", "K072582", "K972423", "K944451", "K970365", "K896547", "K760453", "K897102", "K990905", "K885130", "K003315", "K133173", "K100995", "K913859", "K921733", "K041044", "K051416", "K173912", "K142296", "K924660", "K923156", "K912967", "K955680", "K193133", "K936133", "K151404", "K193077", "K955564", "K932016", "K954749", "K931611", "K210833", "K040014", "K041348", "K972546", "K903435", "K203362", "K913270", "K930895", "K910362", "K961449", "K894613", "K180034", "K182861", "K962175", "K944178", "K922665", "K911080", "K936224", "K955516", "K081440", "K897005", "K954661", "K122932", "K914183", "K971267", "K251313", "K982128", "K952700", "K072148", "K925288", "K933412", "K925438", "K014102", "K022212", "K123699", "K923878", "K890194", "K000964", "K924243", "K150844", "K023918", "K041485", "K964056", "K122235", "K083641", "K142298", "K980466", "K013728", "K172720", "K885129", "K896548", "K030787", "K914088", "K903699", "K894050", "K963732", "K962714", "K093469", "K960429", "K914471", "K170720", "K133597", "K970811", "K945513", "K973829", "K812163" ], "registration_number": [ "3006017180", "3012421607", "3014461810", "3043337628", "3030733800", "3003761012", "3002807314", "3012494290", "1526534", "3008278458", "3008806809", "3014656749", "3012502601", "8010939", "3014579161", "3018094310", "2024841", "8020889", "2011171", "3043226252", "2648727", "3002808022", "3011689956", "1219611", "3011987967", "3009771213", "1314417", "3011137372", "3009518015", "3013188547", "9617604", "3005941719", "3009039068", "3010041511", "1219930", "2032112", "3011237704", "3030446844", "1721686", "3013298431", "8030673", "2936999", "3012542015", "3010220595", "3016678045", "3014479313", "3031233007", "8032044", "1319639", "3027579175", "2025816", "3021632375", "3013557562", "8040412", "3030447506", "8010485", "9681384", "3014054118", "2219920", "3004365956", "3030626857", "1824231", "3009887154", "3008258694", "1928237", "3004551550", "3008132398", "3011088743", "3037918935", "1820334", "3002807561", "3017210488", "1058584", "1219795", "3007502289" ], "fei_number": [ "3006017180", "1000219637", "3012421607", "3014461810", "3043337628", "3030733800", "3003761012", "3002807314", "3003361161", "3012494290", "3003076831", "1526534", "3008278458", "3008806809", "1000138054", "3014656749", "3012502601", "3014579161", "3018094310", "2024841", "2011171", "3043226252", "2648727", "3002808022", "3011689956", "1219611", "3011987967", "3009771213", "1314417", "3009271244", "3009518015", "3013188547", "3003382061", "3009039068", "3010041511", "1219930", "3030446844", "3011237704", "3002806269", "1721686", "3013298431", "3002807626", "2936999", "3012542015", "3002807111", "3010220595", "3016678045", "3014479313", "3031233007", "3004213967", "3027579175", "2025816", "3021632375", "3013557562", "3030447506", "3002808440", "3005747797", "3014054118", "2219920", "3004365956", "3030626857", "1824231", "3002807091", "3009887154", "3008258694", "1928237", "3004551550", "3002807561", "3011088743", "3037918935", "1820334", "1219795", "3017210488", "3002558692", "3007502289" ] } } ] }