{ "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": "34955", "product_res_number": "Z-0243-05", "event_date_initiated": "2004-09-09", "event_date_posted": "2004-11-24", "recall_status": "Terminated", "event_date_terminated": "2012-05-08", "res_event_number": "29990", "product_code": "FMG", "k_numbers": [ "K851986" ], "product_description": "Portex High Pressure 4 - Way Stopcock\nCatalog Number: T8202", "code_info": "Lot numbers starting with: 0, 1, K1, K2, K51, K52", "firm_fei_number": "1217052", "recalling_firm": "Smiths Medical ASD, Inc.", "address_1": "10 Bowman Dr", "city": "Keene", "state": "NH", "postal_code": "03431-5043", "additional_info_contact": "Timothy J. Talcott\n603-352-3812 Ext. 2667", "reason_for_recall": "Sterility of the device is compromised due to packaging defects", "root_cause_description": "Other", "action": "Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.\n\nOn 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K123084", "K823120", "K962581", "K792125", "K823373", "K061143", "K210516", "K792126", "K932512", "K032393", "K911415", "K082110", "K242255", "K770708", "K974083", "K872066", "K913560", "K082836", "K211204", "K860889", "K862492", "K864900", "K190489", "K082106", "K940070", "K080077", "K141254", "K022895", "K800862", "K052330", "K800863", "K902724", "K792128", "K790010", "K223175", "K840394", "K792127", "K782167", "K172266", "K891234", "K760678", "K881805", "K130245", "K060231", "K872067", "K870261", "K954984", "K190539", "K954970", "K842173", "K802258", "K955782", "K012157", "K010217", "K792124", "K864440", "K053405", "K820165", "K780596", "K830198", "K782168", "K760667", "K800864", "K854348", "K823469", "K800284", "K223499", "K812927", "K964435", "K953573", "K961982", "K884463", "K870324", "K041779", "K810375", "K760666", "K780662", "K884435", "K850280", "K770916", "K071400", "K982368", "K853275", "K070143", "K770707", "K862691", "K771911", "K760679", "K851986" ], "device_name": "Stopcock, I.V. Set", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2", "registration_number": [ "3013764800", "3007344957", "1220477", "9617594", "9610849", "2245270", "3009211636", "3005012805", "3012410077", "1526863", "3013188547", "1054241", "2032112", "1030451", "1518293", "2320762", "3013557562", "3030447506", "3002907620", "1928237", "3004111573", "2032098", "8020616", "2011171", "3013517171", "3012809732", "3012261967", "1061124", "3013683058", "3003704957", "3033589330", "1423662", "3015173212", "1644312", "9612152", "1713468", "2022435", "3017636737", "2025816", "3007738736", "3032916632", "3015309643", "3035642068", "9616088", "1423507", "3033536319", "3012536737", "1423537", "3006891665", "1649914", "9613418", "3010432890", "2523676", "9616567", "1000563940", "1625425", "1043214", "8040700", "1416980", "3006475220", "3010041511", "2024024", "9610847", "3015276780", "1047843", "9615817", "1018470", "3006950086", "1424263", "3015085713", "2029275", "3007017524", "3045322464", "3010421104", "1047429", "1055236", "9612052", "2243072", "1060680", "3006425876", "3005941719", "9614279", "1319639", "1223004", "9680794", "3020778", "3012798826" ], "fei_number": [ "3013764800", "3007344957", "1220477", "3003076831", "3003015552", "2245270", "3009211636", "3005012805", "3012410077", "1526863", "3013188547", "1030451", "1000306431", "1518293", "3013557562", "1000117748", "3030447506", "3002907620", "1928237", "3004111573", "3002806588", "1000138054", "2011171", "3013517171", "3012809732", "3012261967", "3013683058", "3003704957", "3033589330", "3015173212", "3008002452", "3002806901", "3001044237", "1713468", "2022435", "3003040625", "3003767881", "3000215273", "3017636737", "2025816", "3007738736", "3032916632", "3015309643", "1000112877", "3035642068", "3033536319", "3012536737", "3002807391", "3006891665", "3002902735", "3003081151", "3010432890", "2523676", "3001236905", "1000563940", "1625425", "1043214", "1416980", "3006475220", "3010041511", "2024024", "3001665800", "1000512168", "3015276780", "1047843", "1018470", "3006950086", "3003807466", "3003058448", "3015085713", "3007017524", "3002806476", "3045322464", "3010421104", "1047429", "3002806443", "2243072", "1000208624", "1000112968", "3006425876", "3002879021", "1000120555", "3002807111", "3003737899", "3002963732", "3020778", "3012798826" ] } } ] }