{ "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": "105983", "product_res_number": "Z-0658-2012", "event_date_initiated": "2011-11-28", "event_date_posted": "2012-01-19", "recall_status": "Terminated", "event_date_terminated": "2014-10-17", "res_event_number": "60449", "product_code": "BTO", "k_numbers": [ "K912469" ], "product_description": "Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5\n\nProduct Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.", "code_info": "Lot numbers: 1774646, 1804348, 1829824, 1842434, 1856172, 1644861, 1651806, 1667770, 1696947, 1713939, 1749571, 1749572, 1754774, 1793497, 1804349, 1821979, 1842435, 1875199, 1887775, 1636039, 1651820, 1648166, 1655826, 1671973, 1683712, 1687748, 1692752, 1696948, 1704632, 1749573, 1774647, 1796678, 1793498, 1821980, 1838654, 1887776, and 1904089. Reorder number: 65P045, 65P050, and 65P055.", "firm_fei_number": "1824231", "recalling_firm": "Smiths Medical ASD, Inc.", "address_1": "5700 W 23rd Ave", "city": "Gary", "state": "IN", "postal_code": "46406-2617", "additional_info_contact": "Cindy Engelhardt, B.S. Ind. Chem., RAC\n603-352-3812 Ext. 2923", "reason_for_recall": "Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory, this may result in decannulation of the tube which could result in serious injury or death; especially if no replacement tracheostomy tube is imm", "root_cause_description": "Device Design", "action": "Smith Medical sent an Urgent Field Safety Notice dated November 28, 2011, via U.S. Mail to all affected consignees. The notice identified the product, description of problem, and actions to be taken. This notice included a Customer Information Bulletin and Urgent Field Safety Notice Confirmation Form. Customers were instructed to 1) identify all affected unused product in inventory and segregate it to a quarantine location; 2) complete and return the attached Confirmation Form by fax to 219-989-7259 or email to bivona.tr3@smiths-medical.com; and 3) distributors were instructed to stop distributing and provide Smith Medical with a list of their customers, including contact details, so that Smith Medical can notify the customers of this notice. For questions contact Smiths Medical Customer Service at 800-258-5361, Option 1.", "product_quantity": "US distribution 153,033 devices ; Foreign 21,490 devices", "distribution_pattern": "Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, \nAustralia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State", "openfda": { "k_number": [ "K060945", "K922749", "K852413", "K021764", "K981080", "K871199", "K873499", "K192511", "K842415", "K962240", "K884427", "K865061", "K772138", "K840539", "K874742", "K810436", "K770218", "K953559", "K841266", "K100950", "K050379", "K880247", "K862436", "K030381", "K031553", "K051587", "K960205", "K862909", "K884015", "K880316", "K852272", "K920281", "K810106", "K843785", "K885139", "K120079", "K062104", "K853419", "K791044", "K853511", "K851016", "K880614", "K100480", "K792069", "K801379", "K822295", "K242921", "K901078", "K882430", "K941470", "K884730", "K923834", "K042684", "K872486", "K832498", "K850446", "K841546", "K810321", "K901079", "K914743", "K834179", "K862267", "K890342", "K823291", "K896798", "K870181", "K855130", "K902281", "K955461", "K100283", "K853051", "K893866", "K810978", "K924195", "K874450", "K831720", "K083031", "K832466", "K925249", "K924191", "K843729", "K851462", "K895130", "K843730", "K811033", "K790930", "K895162", "K802916", "K101721", "K833832", "K924194", "K233713", "K861645", "K173384", "K761258", "K822811", "K894096", "K924193", "K983000", "K820099", "K830509", "K901920", "K790437", "K921281", "K850445", "K811447", "K831511", "K781729", "K945407", "K860176", "K073702", "K903730", "K801931", "K920604", "K030570", "K900548", "K840925", "K912469", "K761190", "K952416", "K810575", "K854252", "K822440", "K862167", "K880317", "K850456", "K912124", "K945406" ], "device_name": "Tube, Tracheostomy (W/Wo Connector)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5800", "device_class": "2", "registration_number": [ "3002808022", "3040279832", "8020889", "3013188547", "1526534", "2029015", "3007740622", "3012494290", "1721686", "3015997711", "1058584", "3013298431", "3018094310", "3011237704", "3001124136", "3021632375", "2521453", "2511556", "2032112", "3012104670", "3016904853", "3003418325", "3023294726", "3027579175", "3003898360", "3014479313", "1825146", "3041276591", "3002907620", "8010485", "1526863", "2936999", "3005609751", "3010419931", "3010400865", "9612030", "3012542015", "3004365956", "1423537", "2518436", "9616567", "1220850", "9681384", "2025816", "3008132398", "1836161", "3014461810", "1721676", "1928237", "1219795", "3010131137", "1319639", "9680661", "8010939", "1824231", "9617604", "3016678045", "1314417", "2024841", "2219920", "3031233007", "3010041511", "3011481350", "3009887154", "3011137372", "1832562", "3013557562", "3005034064", "3030626857", "3014579161", "3030447506", "1921846", "1820334", "3005941719", "3009039068" ], "fei_number": [ "1000160458", "3002808022", "3003361161", "3040279832", "1000138054", "3013188547", "1526534", "1000219637", "3007740622", "3005747797", "3003076831", "3012494290", "3002750084", "1721686", "3001236905", "3015997711", "3013298431", "3018094310", "3002807626", "3002558692", "3011237704", "3001124136", "3021632375", "3003382061", "2521453", "2511556", "3012104670", "3016904853", "3003418325", "3023294726", "3027579175", "3003898360", "3014479313", "1825146", "3041276591", "3002907620", "1526863", "2936999", "3005609751", "3010419931", "3010400865", "3012542015", "3004365956", "2518436", "1220850", "2025816", "3002963732", "3014461810", "1721676", "1928237", "3002807091", "3010131137", "1219795", "1824231", "3002808696", "3016678045", "1314417", "2024841", "2219920", "3031233007", "3010041511", "3011481350", "3009887154", "1832562", "3002808440", "3002806934", "3013557562", "3005034064", "3030626857", "3014579161", "3030447506", "3002807111", "1921846", "1820334", "3009039068" ] } } ] }