{ "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": "189401", "product_res_number": "Z-0155-2022", "event_date_initiated": "2018-05-10", "event_date_created": "2021-10-20", "recall_status": "Terminated", "event_date_terminated": "2023-09-15", "res_event_number": "88725", "product_code": "FMG", "k_numbers": [ "K141254" ], "product_description": "medfusion Stopcock, 1-way and 4-way, Model Numbers (REF):\na. 081-101BE\nb. 081-101GE\nc. 081-101GEE\nd. 081-101NE\ne. 081-102NE\nf. 081-102RE\ng. 089-101E\nh. 888-101NE\ni. 081-102GEE\nj. 888-101BE\nk. 888-101GE\nl. 888-101GEE\nm. 081-101RE\nn. 081-102GE\no. 081-102BE\np. 888-101RE", "code_info": "a. 081-101BE, Serial Numbers: 1570340901, 1570344401, 1570344402  b. 081-101GE, Serial Numbers: 1570343301  c. 081-101GEE, Serial Numbers: 1470293701, 1570343401  d. 081-101NE, Serial Numbers: 1570323801, 1570341001, 1570342701, 1570344101, 1660688101, 1670354301  e. 081-102NE, Serial Numbers: 1660636701  f. 081-102RE, Serial Numbers: 1660636601  g. 089-101E, Serial Numbers: 1570316801, 1570342601, 1570344601, 1660670001, 1670347801, 1670355201, 1670359701  h. 888-101NE, Serial Numbers: 1570343001  i. 081-102GEE, Serial Numbers: 1660636901  j. 888-101BE, Serial Numbers: 1570319201, 1570343101, 1570344201, 1670348101, 1670348102  k. 888-101GE, Serial Numbers: 1570343201, 1660688201  l. 888-101GEE, Serial Numbers: 1470312301, 1570343501  m. 081-101RE, Serial Numbers: 1570342901  n. 081-102GE, Serial Numbers: 1660637101  o. 081-102BE, Serial Numbers: 1570316901, 1660637501  p. 888-101RE, Serial Numbers: 1570344301, 1670356201", "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": "Dave Halverson\n763-383-3310", "reason_for_recall": "Product has a lack of sterility assurance", "root_cause_description": "Package design/selection", "action": "The firm, Smiths Medical, notified their consignees of the recall by issuing an \"URGENT MEDICAL DEVICE FIELD SAFETY NOTICE\" dated 3/2018 on 05/10/2018. The notice described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: \n\nPLEASE TAKE THE FOLLOWING ACTIONS TO HELP US PROPERLY\nEXECUTE THIS FIELD SAFETY CORRECTIVE ACTION:\n1. Identify any affected Infusion Stopcocks in your possession \n2. Determine the number of affected products in your possession and complete the Field Safety Notice (FSN) Response Form attached to this letter within 10 days of receipt; return it to smithsmedicalrecall@stericycle.com. The completed Response Form must be returned even if you do not have any of the affected Infusion Stopcocks in your possession. \n3. All affected products must be returned to Stericycle for processing. If the completed Response Form indicates that you have product to return.\n4. When you receive the pre-paid shipping labels, package the affected products by lot number. Include a copy of the completed Response Form inside EACH BOX of returned products.\n5. FOR DISTRIBUTORS ONLY: If you have distributed any of the affected products to your customers, please immediately notify your customers of this Field Safety Corrective Action and retrieve all affected products.\n\nIf you have any questions regarding this notification, contact Stericycle via email at the following address: smithsmedicalrecall@stericycle.com.", "product_quantity": "933,518 units", "distribution_pattern": "International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.", "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" } } ] }