{ "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": "210758", "product_res_number": "Z-0528-2025", "event_date_initiated": "2024-10-28", "event_date_posted": "2024-11-25", "recall_status": "Open, Classified", "res_event_number": "95605", "product_code": "BSR", "product_description": "smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP", "code_info": "REF 14-504-68, UDI/DI 35021239002586, Lot Numbers: 0003393, 0003394, 0003357, 0003358, 0003267, 0003368, 0003634, 0003254, 0003369, 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003256, 0003300, 0003307, 0003308, 0003314, 0003322, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003377, 0003380, 0003635, 0003643; \nREF 14-504-68JP, UDI/DI 35021239002586, Lot Numbers: 0003369, 0003377, 0003393, 0003394, 0003634, 0003635, 0003643", "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": "763-383-3072", "reason_for_recall": "Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.", "root_cause_description": "Under Investigation by firm", "action": "Smiths Medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 10/28/2024, mailed using a traceable means. The notice explained the issue, potential risk, and requested the consignee locate and destroy all affected products, and distribute the notice to all affected parties. Distributors were directed to notify their customers. \nFor questions: \nAbout the communication: smithsmedical7602@sedgwick.com, 1-800-913-3897; \nTo report adverse events: globalcomplaints@icumed.com, 1-866-216-8806", "product_quantity": "10,223 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K904999", "K912690", "K932081", "K920468", "K772046", "K844557", "K953677", "K162729", "K954771", "K843490", "K905052", "K952100", "K955238", "K935797", "K962361", "K802416", "K943104", "K910659", "K922842", "K952266", "K905133", "K914965", "K832773", "K950380", "K902180", "K940799", "K865108", "K921128", "K933598", "K770374", "K950713", "K944729" ], "registration_number": [ "", "3042022216", "3007829657", "3010594263", "1058584", "3006446479", "8020785", "3004056932", "3003528228", "3007728072", "1825146", "3005609751", "3013528571", "3010396739", "1423662", "1047843", "2025816", "2183828", "3042248499", "3015966505", "1045254", "3006787036", "3005327291", "3010202439", "3021010418", "9617604", "8022032", "3004527595", "3007421149", "9615393", "3010402691", "2022648", "9612501", "2032273", "3003213883", "3009746061", "3011600579", "3001313714", "3011497859", "1721686", "1720929", "3018094310", "3003898360", "3010149039", "3004111573", "2936999", "3022472", "1048735", "3000247987", "3002675176", "3011050534", "3014208300", "1314417", "3010041511", "9680143", "3004748541", "1061927", "2020550", "3016734145", "3003674698", "3030733800", "9613073", "8020889", "3006061749", "8040510", "3004992992", "3012494290", "3015216264", "2183650", "3018366470", "3005273623", "9680721", "8030673", "3018503755", "8040412", "3045058049", "3010400865", "3018762668", "3024026674", "9681384", "9680222", "3006973666", "1836161", "3009771213", "8044169", "3010131137", "9614084", "3011237770", "8021995", "3015152450", "3017166758", "3013557562", "3018074706", "3012970776", "1820334", "3013503739", "3011987967", "3000279801", "3009039068", "3013188547", "3014544429", "3016634868", "3013576541", "3003965134", "3011252788", "3008806809", "8040278", "3013412170", "3012287892", "3008808049", "3006389770", "3010220595", "3006210673", "3002807267", "9616567", "3007127332", "3022518300", "3020984207", "3006157842", "3003477135", "1928237", "3006897996", "2183744", "3006542380", "8010939", "3015142721", "3021244152", "3011137372", "3033010858", "3010834934", "3014579161", "3012991986", "3013055504", "3008676146" ], "fei_number": [ "", "3042022216", "3007829657", "1000219637", "3005747797", "3010594263", "3006446479", "3004056932", "3003528228", "3007728072", "1825146", "3005609751", "3013528571", "3010396739", "1047843", "2025816", "2183828", "3042248499", "3015966505", "1045254", "3006787036", "3005327291", "3021010418", "3004527595", "3001620388", "3007421149", "3004216008", "3010402691", "2022648", "3009291251", "3003213883", "3009746061", "3011600579", "3001717360", "3011497859", "3003154916", "3002750084", "1721686", "1720929", "3018094310", "3002807626", "3003898360", "3010149039", "3004111573", "2936999", "3022472", "3009271244", "1048735", "3001319476", "3000247987", "3002675176", "3011050534", "3014208300", "1314417", "3010041511", "3004748541", "3002808440", "2020550", "3016734145", "3003674698", "3030733800", "3005947796", "3003495548", "3006061749", "3004992992", "3012494290", "3015216264", "2183650", "3018366470", "3002807308", "3005273623", "3007475226", "3018503755", "3045058049", "3010400865", "3018762668", "3024026674", "3006973666", "3002963732", "3009771213", "3010131137", "3011237770", "3000215273", "3015152450", "3017166758", "1000283452", "3013557562", "3018074706", "3012970776", "1820334", "3013503739", "3011987967", "3000279801", "3009039068", "3000203000", "3013188547", "3014544429", "3016634868", "3013576541", "3003965134", "3011252788", "3002558692", "3006363476", "3008806809", "3003382061", "3013412170", "3012287892", "3008808049", "3006389770", "3010220595", "3006210673", "3002807267", "3007127332", "3022518300", "3020984207", "3006157842", "3003477135", "1928237", "3006897996", "2183744", "3006542380", "1000244733", "3003240904", "3015142721", "3004213967", "3021244152", "3003927064", "3033010858", "3010834934", "3014579161", "3012991986", "3002807293", "3013055504", "3008676146" ], "device_name": "Stylet, Tracheal Tube", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5790", "device_class": "1" } } ] }