{ "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": "167075", "product_res_number": "Z-0069-2019", "event_date_initiated": "2018-08-20", "event_date_created": "2018-10-04", "recall_status": "Completed", "res_event_number": "80946", "product_code": "FMG", "k_numbers": [ "K964435" ], "product_description": "ICU Medical 14\" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28\n\n The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).", "code_info": "lots: 85-540-SJ, 86-189-SL, 86-911-SJ", "firm_fei_number": "2025816", "recalling_firm": "ICU Medical, Inc.", "address_1": "951 Calle Amanecer", "city": "San Clemente", "state": "CA", "postal_code": "92673-6212", "reason_for_recall": "Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.", "root_cause_description": "Device Design", "action": "On 08/20/18, the firm, icumedical, mailed \"URGENT MEDICAL DEVICE RECALL\" l notices to consignees. The notice described the product, problem and actions to be taken. If product has been further distributed, the firm requested consignees to notify users. Customers were advised to return affected product only if the blood filter is needed. Customers needing response forms and/or return labels were advised to call 1-800-479-0551.\n\n For further inquiries call: 1-866-829-9025.", "product_quantity": "2361 Units", "distribution_pattern": "U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.", "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" ] } } ] }