{ "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": "140927", "product_res_number": "Z-0269-2016", "event_date_initiated": "2015-09-23", "event_date_created": "2015-11-12", "recall_status": "Terminated", "event_date_terminated": "2016-11-28", "res_event_number": "72396", "product_code": "BTO", "product_description": "Ventilator Tubing", "code_info": "Model\tLength\tLot Numbers KC 036\t36 tube\tP0614015, P0818215, P0825515  KC 060\t60 tube\tP0511915, P0608315 KC 072\t72 tube\tP0618415, P0818515", "firm_fei_number": "2518436", "recalling_firm": "Instrumentation Industries Inc", "address_1": "2990 Industrial Blvd", "city": "Bethel Park", "state": "PA", "postal_code": "15102-2536", "additional_info_contact": "412-854-1133", "reason_for_recall": "As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage", "root_cause_description": "Nonconforming Material/Component", "action": "Instrumentation Industries notified consignees by e-mail and telephone of the recall. The firm also sent a Notice of Product Recall letter dated September 23, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to determine if they have any of the affected product and contact the firm to make arrangements for return to Instrumentation Industries, Inc. Replacement product will be sent as soon as possible after all quality inspections have been completed. If product was further distributed consignees were asked to provide recall information to their customers. Customers with questions should call 412-854-1133, ext 433.", "product_quantity": "567", "distribution_pattern": "Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.", "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" ] } } ] }