{ "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": "169042", "product_res_number": "Z-0512-2019", "event_date_initiated": "2018-11-19", "event_date_created": "2019-07-05", "recall_status": "Terminated", "event_date_terminated": "2020-06-05", "res_event_number": "81599", "product_code": "FMG", "product_description": "Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.", "code_info": "Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "reason_for_recall": "Certain lots of Medex\" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak.\n\nModel Number - Lot Number\nMX4301L - 3538569\nMX4331L - 3562377 & 3546826\nMX4331R - 3546924", "root_cause_description": "Equipment maintenance", "action": "Smiths Medical notified customers on about 11/19/2018 via email with the attached \"URGENT MEDICAL DEVICE RECALL NOTICE.\"\n\n\nDistributors were instructed to immediately notify customers to whom they have distributed affected product to of the Recall Notice. They were also instructed to follow the following steps: \n1. Locate affected product in your possession by referring to the attached Response Form. This form identifies specific affected product that Smiths Medical shipped to your facility. \n2. Determine the number of affected devices in your possession and complete the attached Response Form within 10 days of receipt, returning it to fieldactions@smiths-medical.com. This form must be returned even if you do not have any affected product in your possession. \n3. Upon receipt of the completed Response Form, a shipping label will be issued to you for use in returning your affected product for processing.\nPackage the affected products securely and include a copy of the completed Response Form inside each box, ensuring boxes are sealed and labeled with your facility name prior to shipping. Credit will be processed when your completed Response Form is received and once returned affected products have been processed.", "product_quantity": "2,425 devices", "distribution_pattern": "The potentially affected products were shipped to customers in the US, Canada, and Mexico.", "openfda": { "k_number": [ "K800862", "K052330", "K760678", "K932512", "K041779", "K790010", "K022895", "K792126", "K810375", "K853275", "K884435", "K823120", "K061143", "K940070", "K760666", "K082836", "K800863", "K851986", "K760679", "K771911", "K872067", "K864900", "K884463", "K954984", "K820165", "K242255", "K800864", "K010217", "K812927", "K842173", "K760667", "K770707", "K881805", "K782167", "K961982", "K082106", "K053405", "K962581", "K223175", "K854348", "K891234", "K870261", "K954970", "K211204", "K840394", "K792128", "K012157", "K862691", "K071400", "K800284", "K792124", "K782168", "K080077", "K982368", "K770708", "K974083", "K860889", "K780662", "K830198", "K870324", "K060231", "K964435", "K792127", "K911415", "K913560", "K210516", "K953573", "K130245", "K955782", "K792125", "K862492", "K823469", "K223499", "K850280", "K123084", "K172266", "K902724", "K872066", "K190489", "K070143", "K082110", "K190539", "K141254", "K823373", "K864440", "K802258", "K770916", "K032393", "K780596" ], "registration_number": [ "3010432890", "1060680", "1649914", "3020778", "3006891665", "2029275", "1416980", "1423507", "3007017524", "1713468", "1047429", "1423662", "1047843", "2025816", "1000563940", "3006950086", "3012261967", "9610849", "1625425", "3007344957", "3015276780", "1223004", "9612052", "2011171", "3012798826", "1644312", "2032112", "2245270", "3004111573", "3003704957", "3015309643", "2523676", "3007738736", "9616088", "2024024", "1220477", "1018470", "3010041511", "1518293", "3017636737", "3005941719", "9610847", "3013517171", "9615817", "3045322464", "3010421104", "3009211636", "8020616", "3006475220", "9612152", "3002907620", "3012809732", "3032916632", "1423537", "1043214", "8040700", "9617594", "1424263", "3015173212", "1061124", "3013557562", "9614279", "3030447506", "2243072", "3013188547", "1055236", "2032098", "3033589330", "3012536737", "3015085713", "3013683058", "1030451", "1526863", "9616567", "3013764800", "2022435", "9613418", "1928237", "1319639", "3035642068", "3033536319", "9680794", "1054241", "3005012805", "2320762", "3006425876", "3012410077" ], "fei_number": [ "3010432890", "1000138054", "3002902735", "3020778", "3001236905", "3006891665", "1416980", "1000208624", "3007017524", "1713468", "1047429", "3003040625", "1047843", "2025816", "3002807391", "1000563940", "3006950086", "3012261967", "3002807111", "1625425", "3007344957", "3015276780", "3002879021", "2011171", "3003076831", "3012798826", "1000120555", "2245270", "1000306431", "3003081151", "3002806588", "3004111573", "3003704957", "3015309643", "2523676", "3007738736", "3001044237", "2024024", "1220477", "1018470", "3010041511", "3003058448", "3002806476", "1518293", "3017636737", "3008002452", "3013517171", "3045322464", "3010421104", "3009211636", "3001665800", "3006475220", "3002907620", "3012809732", "3032916632", "3002806443", "1043214", "1000112968", "3002963732", "3003737899", "1000512168", "3000215273", "3015173212", "3013557562", "3030447506", "2243072", "1000117748", "3013188547", "1000112877", "3002806901", "3033589330", "3012536737", "3015085713", "3013683058", "1030451", "1526863", "3013764800", "2022435", "3003015552", "1928237", "3003767881", "3035642068", "3033536319", "3005012805", "3006425876", "3003807466", "3012410077" ], "device_name": "Stopcock, I.V. Set", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }