{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217947", "product_res_number": "Z-1203-2026", "event_date_initiated": "2025-12-26", "event_date_posted": "2026-01-28", "recall_status": "Open, Classified", "res_event_number": "98228", "product_code": "GCX", "product_description": "Chest Drainage Units and Accessories:\n\nProduct Code\tDescription\n\n1. 8888571562\tCardinal Health Sentinel Seal CDU\n2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain\n3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change\nConnector\n4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector\n5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction\n6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain\n7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy\nChange Connector\n8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000\nmL\n9. 1814713105\tOUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only)\n10. 1180571570\tOUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL\n11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL\n12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber,\n2500 mL", "code_info": "All units affected by IFU update.\n\nUDI-DI:\n\n1. 8888571562\tCardinal Health Sentinel Seal CDU\n50192253003091 (CS)\n10192253003093 (EA)\n\n2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain\n50192253003084 (CS)\n10192253003086 (EA)\n\n3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change\nConnector\n50192253003077 (CS)\n10192253003079 (EA)\n\n4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector\n50192253003039 (CS)\n10192253003031 (EA)\n\n5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction\n50192253003015 (CS)\n10192253003017 (EA)\n\n6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain\n50192253003060 (CS)\n10192253003062 (EA)\n\n7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy\nChange Connector\n50192253003022 (CS)\n10192253003024 (EA)\n\n8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000\nmL\n50192253002643 (CS)\n10192253002645 (EA)\n\n9. 1814713105\tOUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only)\n50192253002308 (CS)\n10192253002300 (CS)\n\n10. 1180571570\tOUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL\n50192253002292 (CS)\n10192253002294 (EA)\n\n11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL\n50192253002650 (CS)\n10192253002652 (EA)\n\n12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber,\n2500 mL\n50192253002667 (CS)\n10192253002669 (EA)", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "additional_info_contact": "Customer Service\n888-444-5440", "reason_for_recall": "The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.", "root_cause_description": "Error in labeling", "action": "On December 26, 2025, the firm notified customers via Urgent Medical Device Product Advisory letters. Customers were instructed to continuing utilizing the CDUs on adult patients (not pediatric patients or infants). The updated IFU for affected product codes can be found at https://www.mycardinalmsds.com/", "product_quantity": "1,169,726 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.", "openfda": { "k_number": [ "K760812", "K861261", "K902089", "K831116", "K896804", "K813066", "K914601", "K771737", "K961880", "K905448", "K844882", "K781988", "K801979", "K881252", "K931548", "K924577", "K963648", "K920912", "K802440", "K833673", "K911238", "K972074", "K822311", "K833674", "K971022", "K821841", "K821160", "K950464", "K924337", "K760217", "K820424", "K813319", "K844881", "K964127", "K896556", "K962920", "K790055", "K884103", "K821023", "K964519", "K896563", "K823037", "K910377", "K896562", "K760216", "K760814", "K896558", "K885208", "K760333", "K820337", "K924570", "K870874", "K890129", "K894695", "K890431", "K885334", "K954726", "K920248", "K952219", "K895859", "K042454", "K813029", "K893741", "K895039", "K820765", "K880704", "K892549", "K813394", "K801942", "K874505", "K951119", "K992126", "K896134", "K960223", "K822005", "K912753", "K853095", "K812845", "K896557", "K954869", "K873489", "K910218", "K831939", "K893649", "K851384", "K901937", "K760813" ], "registration_number": [ "", "3021244152", "1818910", "2028807", "2133713", "3005987240", "3003674698", "3010707607", "2529846", "2022724", "1034117", "1017294", "9610531", "3016050940", "3012447612", "3007303113", "3010041511", "3001104093", "3012445205", "1526439", "3014420084", "3014926389", "1223925", "3014388471", "3013735622", "8030673", "8010273", "3004438577", "3004111573", "1047843", "1419951", "3007305485", "3004491689", "3005587132", "3005595283", "9614434", "1000523114", "2640138", "3003481016", "9616088", "1423395", "3007092328", "3015967359", "3006897996", "3042350604", "2320762", "3010966951", "3016080683", "9610612", "3018074706", "3023809973", "2029015", "3004137296", "3012494290", "3010834934", 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"3007681502", "3009888344", "3020796687", "1423537", "3013055504", "2435946", "3005669815", "3008797953", "1216677", "1422634", "1043214", "3030979378", "3008264111", "3030558088", "3017540705", "1424785", "3010202439", "3007649127", "3013530901", "3005273623", "3006446479", "3011182134", "3012075008", "3014656668", "2032112", "2518417", "3008624479", "3006395447", "1054241", "1921846", "3014342096", "1526012", "1424263", "1319639", "3015978022", "1000153536", "3016601021", "3042940358", "9680260", "9610617", "3013557562", "1926681", "9614209", "1623486", "3004874794", "3010170586", "3004839227", "1417592", "3010221586", "1834244", "8010177", "2936485", "3016147813", "1219659", "3007829657", "2648666", "3002732769", "3004096300", "3010155661", "3045058049", "1032347", "3006606984", "2648623", "3042250743" ], "fei_number": [ "", "1000136269", "3021244152", "1818910", "1000220700", "3005987240", "3003674698", "1000142697", "3010707607", "2022724", "1034117", "1017294", "3007475226", 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"1000137528", "3004476158", "3030516433", "3043009869", "3002807907", "3005747797", "3002808026", "2011171", "3005528784", "2080309", "3043355002", "3014421917", "1643817", "3010396502", "3010373530", "1000138054", "3016426850", "1314417", "3001236905", "3003473212", "1000305720", "3002807421", "2649614", "3002902735", "3016248619", "3003015552", "1000112968", "3012341425", "3013532143", "3024787345", "3033920060", "3023530182", "3018503755", "1018470", "3038637162", "2020550", "3027977504", "3027645317", "3005440795", "3002806725", "1924066", "3013234390", "1713468", "1000136191", "2916714", "3003620648", "3029917416", "2016945", "2648209", "1000306431", "3015168845", "3013345545", "1319211", "3007681502", "3009888344", "3020796687", "3013055504", "1000514656", "3005669815", "3008797953", "1216677", "1043214", "3030979378", "3008264111", "3030558088", "3017540705", "1000374126", "3007649127", "3013530901", "3005273623", "3006446479", "3002821504", "3011182134", "3012075008", "3014656668", "3004213967", "3000209940", "2518417", "3008624479", "3006395447", "1921846", "3014342096", "1526012", "3015978022", "1000153536", "3016601021", "3042940358", "3013557562", "1926681", "3003040625", "1623486", "3004874794", "3010170586", "3004839227", "1417592", "3010221586", "3003469115", "2936485", "3016147813", "1219659", "3002807373", "3007829657", "2648666", "3002732769", "3004096300", "3010155661", "3045058049", "1032347", "3006606984", "2648623", "3042250743" ], "device_name": "Apparatus, Suction, Operating-Room, Wall Vacuum Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.6740", "device_class": "2" } } ] }