{ "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. 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202105201X, 202105383X, 202105384X, 202105385X, 202106264X, 202106265X, 202106313X, 202106314X, 202106315X, 202106316X, 202107063X, 202107064X, 202107065X, 202107113X, 202107114X, 202107115X, 202107116X, 202107202X, 202108121X, 202108187X, 202108188X, 202108230X, 202202326X, 202203066X, 202203409X, 202208021X, 202209336X, 21G0922JZX, 22C1430JZX, 22C1432JZX;\n\n9CN90H/20884521176352/21C0411JZX, 21C0412JZX, 21D0464JZX, 21D0465JZX, 21D0601JZX, 21I0555JZX, 21I0556JZX, 21K0262JZX, 21K0263JZX;\n\n9CN90R/10884521205468/202105281X, 202110114X, 202202327X, 202204166X, 202205514X;\n\n9UN90H/20884521176284/21E0657JZX, 21E0658JZX;\n\n9UN90R/10884521205536/202203308X, 21F0328JZX", "firm_fei_number": "2936999", "recalling_firm": "Covidien", "address_1": "6135 Gunbarrel Ave", "city": "Boulder", "state": "CO", "postal_code": "80301-3214", "additional_info_contact": "Technical Support\n800-255-6774 Ext. 4", "reason_for_recall": "A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.", "root_cause_description": "Component change control", "action": "On 3/24/23, recall notices were mailed to risk managers and directors of respiratory care.\n\nTracheostomy Tubes that do not securely attach or stay attached to caps or accessories should not be used.\n\n1) All affected unused product should be quarantined and returned to the recalling firm.\n2) Complete and then return the customer confirmation form to rs.gmbfcamitg@medtronic.com\n3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.\n4) If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor.\n\nCustomers with questions can contact Quality Assurance at 800-255-6774, option 4.", "product_quantity": "599,187", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of PR, CA, FL, MN, PA, AZ, IL, TN, OH, MI, GA, KS, HI, MD, AK, NY, NE, IA, OK, VA, ND, MO, NC, SC, KY, OR, IN, WA, TX, WI, CT, MA, WV, CO, VT, NJ, SD, AR, AL, MS, LA, DE, MT, WY, DC, UT, NV, NH, RI, ID, NM, ME and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bolivia, Plurinational State Of Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Malta, Martinique, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic Of Tanzania, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, Viet Nam.", "openfda": { "k_number": [ "K962078", "K072582", "K151404", "K970811", "K133597", "K896547", "K973829", "K897005", "K896548", "K093469", "K043160", "K924660", "K925288", "K030787", "K251313", "K962175", "K897102", "K936133", "K170720", "K945874", "K123699", "K133528", "K980466", "K931611", "K990905", "K933412", "K897059", "K142298", "K903435", "K041044", "K011210", "K041485", "K031057", "K970365", "K040014", "K193077", "K083641", "K962173", "K972385", "K955680", "K894613", "K122932", "K150844", "K913859", "K944178", "K960429", "K925438", "K122235", "K193133", "K972546", "K914088", "K955564", "K923156", "K172720", "K051416", "K903699", "K913270", "K932016", "K890194", "K122531", "K955516", "K023918", "K894614", "K003315", "K925020", "K924243", "K972423", "K971267", "K911080", "K203362", "K923878", "K885130", "K133173", "K210833", "K914183", "K944451", "K963732", "K180034", "K100995", "K922665", "K013728", "K945513", "K812302", "K885129", "K081440", "K961449", "K912967", "K072148", "K962714", "K760453", "K894050", "K142296", "K182861", "K954749", "K921733", "K000964", "K936224", "K041348", "K964056", "K914471", "K022212", "K173912", "K812163", "K910362", "K954661", "K952700", "K930895", "K014102", "K982128" ], "registration_number": [ "3011237704", "9617604", "3021632375", "3002807314", "2024841", "3005941719", "8010485", "8010939", "8030673", "1314417", "1219930", "3002808022", "1219611", "3011137372", "3011689956", "1319639", "1219795", "3030446844", "1820334", "3043337628", "2648727", "3014579161", "1928237", "3008132398", "3012421607", "3027579175", "2025816", "1526534", "3006017180", "3014461810", "2936999", "3004551550", "3037918935", "8032044", "3012494290", "2011171", "3003761012", "3012502601", "3011088743", "3043226252", "3002807561", "2219920", "3009887154", "3012542015", "3009771213", "3009039068", "3018094310", "2032112", "9681384", "3008258694", "3014479313", "3007502289", "3013188547", "8040412", "3017210488", "3014054118", "3009518015", "3010041511", "3013557562", "3011987967", "3004365956", "3031233007", "8020889", "3013298431", "1721686", "1058584", "3008806809", "3030733800", "3008278458", "3030447506", "3016678045", "3010220595", "3014656749", "3030626857" ], "fei_number": [ "3002806269", "3011237704", "3021632375", "3002807314", "2024841", "1314417", "1219930", "3009271244", "3002808022", "1219611", "3011689956", "1219795", "3030446844", "1000219637", "1820334", "3043337628", "2648727", "3014579161", "1928237", "3027579175", "3012421607", "2025816", "3003361161", "1526534", "3004213967", "3006017180", "3014461810", "2936999", "3004551550", "3037918935", "3012494290", "2011171", "1000138054", "3003761012", "3012502601", "3005747797", "3011088743", "3043226252", "3002808440", "3002807561", "3002807626", "2219920", "3009887154", "3012542015", "3002807091", "3009771213", "3009039068", "3018094310", "3008258694", "3014479313", "3002807111", "3007502289", "3013188547", "3017210488", "3014054118", "3009518015", "3010041511", "3013557562", "3011987967", "3004365956", "3031233007", "3003076831", "3013298431", "1721686", "3030733800", "3008806809", "3008278458", "3030447506", "3016678045", "3010220595", "3003382061", "3002558692", "3014656749", "3030626857" ], "device_name": "Tube Tracheostomy And Tube Cuff", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5800", "device_class": "2" } } ] }