{ "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": "184917", "product_res_number": "Z-0726-2021", "event_date_initiated": "2020-12-15", "event_date_created": "2020-12-28", "recall_status": "Terminated", "event_date_terminated": "2022-12-20", "res_event_number": "86954", "product_code": "JOH", "k_numbers": [ "K944178" ], "product_description": "PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45", "code_info": "Lot Number 3991195", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "Dave Halverson\n763-383-3072", "reason_for_recall": "A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.", "root_cause_description": "Packaging process control", "action": "The firm initiated the recall by letter on 12/15/2020. The letter requested the following:\n\"INSTRUCTIONS TO CUSTOMERS AND DISTRIBUTORS:\n\n1.\tLocate affected product in your possession by referring to the Affected Devices List (Table 1) listed on this Recall Notice.\n\n2.\tDetermine the number of affected devices in your possession and complete the Response Form (Attachment 1) within 10 days of receipt, returning it to fieldactions@smiths-medical.com. The form must be returned even if you do not have any affected Bivona Cuffless FlexTend Tracheostomy Tube Devices in your possession.\n\n3.\tAll affected product must be returned to Smiths Medical for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. When returning product please include a copy of the Response Form (Attachment 1) inside EACH BOX.\n\n4.\tProduct credit will be processed once the impacted product and Response Form (Attachment 1) has been received and processed.\n\n5.\tDISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall with the editable Response Form for your customers (Attachment 1a) to respond appropriately.\"", "product_quantity": "238 devices", "distribution_pattern": "US nationwide distribution.", "openfda": { "k_number": [ "K142298", "K173912", "K041044", "K093469", "K970365", "K952700", "K910362", "K911080", "K962078", "K944178", "K251313", "K170720", "K122235", "K896547", "K011210", "K930895", "K180034", "K963732", "K961449", "K133173", "K933412", "K043160", "K962714", "K972423", "K931611", "K890194", "K897005", "K923156", "K013728", "K923878", "K970811", "K193077", "K172720", "K945513", "K030787", "K083641", "K760453", "K896548", "K031057", "K973829", "K924243", "K960429", "K913859", "K914088", "K972385", "K921733", "K150844", "K142296", "K123699", "K913270", "K903435", "K072582", "K812302", "K936133", "K903699", "K885129", "K955516", "K914183", "K003315", "K100995", "K922665", "K894050", "K894613", "K812163", "K945874", "K897102", "K954749", "K936224", "K962175", "K954661", "K955564", "K014102", "K041348", "K022212", "K980466", "K925288", "K041485", "K885130", "K151404", "K990905", "K914471", "K972546", "K023918", "K122932", "K182861", "K051416", "K971267", "K964056", "K122531", "K897059", "K925438", "K962173", "K210833", "K944451", "K925020", "K894614", "K040014", "K955680", "K000964", "K081440", "K133528", "K072148", "K203362", "K924660", "K193133", "K133597", "K982128", "K932016", "K912967" ], "registration_number": [ "3030733800", "3002808022", "8020889", "2011171", "1526534", "3013188547", "3012494290", "3014656749", "1721686", "3012421607", "1058584", "3013298431", "3008806809", "3017210488", "3018094310", "3011237704", "3021632375", "1824231", "3008258694", "2032112", "3009518015", "1219611", "3027579175", "2648727", "8030673", "3014479313", "3043226252", "8010485", "3011689956", "8040412", "2936999", "3012542015", "3010220595", "3004365956", "9681384", "3037918935", "2025816", "3007502289", "3008132398", "3014461810", "3009771213", "1928237", "1219795", "1319639", "8010939", "3014054118", "3043337628", "9617604", "3004551550", "3016678045", "1314417", "3030446844", "2024841", "2219920", "3011088743", "8032044", "3008278458", "3002807314", "3010041511", "3031233007", "3002807561", "3009887154", "3011137372", "3006017180", "3013557562", "3030626857", "1219930", "3014579161", "3030447506", "1820334", "3011987967", "3005941719", "3009039068", "3012502601", "3003761012" ], "fei_number": [ "3030733800", "3002808022", "3003361161", "1000138054", "2011171", "1526534", "1000219637", "3002806269", "3005747797", "3013188547", "3003076831", "3012494290", "3014656749", "1721686", "3012421607", "3017210488", "3013298431", "3008806809", "3018094310", "3002807626", "3011237704", "3003382061", "3021632375", "1824231", "3008258694", "3009518015", "1219611", "3027579175", "2648727", "3014479313", "3043226252", "3011689956", "2936999", "3012542015", "3009271244", "3010220595", "3004365956", "3037918935", "2025816", "3007502289", "3014461810", "3009771213", "1928237", "3002807091", "1219795", "3014054118", "3043337628", "3004551550", "3016678045", "1314417", "3004213967", "3030446844", "2024841", "2219920", "3011088743", "3031233007", "3008278458", "3002807314", "3010041511", "3002807561", "3002558692", "3009887154", "3002808440", "3006017180", "3013557562", "3030626857", "3014579161", "3030447506", "3002807111", "1820334", "3011987967", "1219930", "3009039068", "3012502601", "3003761012" ], "device_name": "Tube Tracheostomy And Tube Cuff", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5800", "device_class": "2" } } ] }