{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203239", "product_res_number": "Z-0205-2024", "event_date_initiated": "2023-08-22", "event_date_posted": "2023-10-31", "recall_status": "Open, Classified", "res_event_number": "92996", "product_code": "JOH", "k_numbers": [ "K083641" ], "product_description": "Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.", "code_info": "Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.", "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": "Tom McCall\n949-366-4368", "reason_for_recall": "The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).", "root_cause_description": "Labeling mix-ups", "action": "On 8/22/2023, a third-party recall notification service issued recall notifications to the direct accounts on behalf of the recalling firm via UPS ground. The letter explained the reason for the notification and embedded pictures of the incorrect and correct labels into the letter. The letter also provided the potential risk and required actions for users. The potential risk involves the potential for a customer to assess the product as expired, resulting in the potential for a delay in the availability to use the tracheostomy device. If the customer did not identify the incorrect device unit carton/secondary packaging labeling upon receipt and provided the items to clinicians, the individual device tray/primary packaging would still allow correct identification of the expiration date at the point of use, as the expiry date on the individual unit is correctly labeled.\n\nThe required actions included (1) informing potential users within their organization of the notification and to complete and return the attached response form via email within ten days of receipt to acknowledge if they have the affected product and/or if it has already been used; and (2) if the account has further distributed the product, immediately notify those customers of the field correction. The letter instructs that if the product has not already been used, the product must be used before the correct expiry of March 17, 2026.", "distribution_pattern": "Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution.\n\nForeign distribution was made to Canada.", "openfda": { "device_name": "Tube Tracheostomy And Tube Cuff", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5800", "device_class": "2", "k_number": [ "K962173", "K962078", "K812302", "K925020", "K122531", "K031057", "K972385", "K894614", "K897059", "K945874", "K011210", "K133528", "K043160", "K072582", "K972423", "K944451", "K970365", "K896547", "K760453", "K897102", "K990905", "K885130", "K003315", "K133173", "K100995", "K913859", "K921733", "K041044", "K051416", "K173912", "K142296", "K924660", "K923156", "K912967", "K955680", "K193133", "K936133", "K151404", "K193077", "K955564", "K932016", "K954749", "K931611", "K210833", "K040014", "K041348", "K972546", "K903435", "K203362", "K913270", "K930895", "K910362", "K961449", "K894613", "K180034", "K182861", "K962175", "K944178", "K922665", "K911080", "K936224", "K955516", "K081440", "K897005", "K954661", "K122932", "K914183", "K971267", "K251313", "K982128", "K952700", "K072148", "K925288", "K933412", "K925438", "K014102", "K022212", "K123699", "K923878", "K890194", "K000964", "K924243", "K150844", "K023918", "K041485", "K964056", "K122235", "K083641", "K142298", "K980466", "K013728", "K172720", "K885129", "K896548", "K030787", "K914088", "K903699", "K894050", "K963732", "K962714", "K093469", "K960429", "K914471", "K170720", "K133597", "K970811", "K945513", "K973829", "K812163" ], "registration_number": [ "3006017180", "3012421607", "3014461810", "3043337628", "3030733800", "3003761012", "3002807314", "3012494290", "1526534", "3008278458", "3008806809", "3014656749", "3012502601", "8010939", "3014579161", "3018094310", "2024841", "8020889", "2011171", "3043226252", "2648727", "3002808022", "3011689956", "1219611", "3011987967", "3009771213", "1314417", "3011137372", "3009518015", "3013188547", "9617604", "3005941719", "3009039068", "3010041511", "1219930", "2032112", "3011237704", "3030446844", "1721686", "3013298431", "8030673", "2936999", "3012542015", "3010220595", "3016678045", "3014479313", "3031233007", "8032044", "1319639", "3027579175", "2025816", "3021632375", "3013557562", "8040412", "3030447506", "8010485", "9681384", "3014054118", "2219920", "3004365956", "3030626857", "1824231", "3009887154", "3008258694", "1928237", "3004551550", "3008132398", "3011088743", "3037918935", "1820334", "3002807561", "3017210488", "1058584", "1219795", "3007502289" ], "fei_number": [ "3006017180", "1000219637", "3012421607", "3014461810", "3043337628", "3030733800", "3003761012", "3002807314", "3003361161", "3012494290", "3003076831", "1526534", "3008278458", "3008806809", "1000138054", "3014656749", "3012502601", "3014579161", "3018094310", "2024841", "2011171", "3043226252", "2648727", "3002808022", "3011689956", "1219611", "3011987967", "3009771213", "1314417", "3009271244", "3009518015", "3013188547", "3003382061", "3009039068", "3010041511", "1219930", "3030446844", "3011237704", "3002806269", "1721686", "3013298431", "3002807626", "2936999", "3012542015", "3002807111", "3010220595", "3016678045", "3014479313", "3031233007", "3004213967", "3027579175", "2025816", "3021632375", "3013557562", "3030447506", "3002808440", "3005747797", "3014054118", "2219920", "3004365956", "3030626857", "1824231", "3002807091", "3009887154", "3008258694", "1928237", "3004551550", "3002807561", "3011088743", "3037918935", "1820334", "1219795", "3017210488", "3002558692", "3007502289" ] } } ] }