{ "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": "105972", "product_res_number": "Z-0480-2012", "event_date_initiated": "2011-12-06", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-11-01", "res_event_number": "60608", "product_code": "FMG", "k_numbers": [ "K962581" ], "product_description": "Baxter Interlink System Continu-Flo Solution Set, 71\" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock, Extension Set, 39\" (99 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, Extension Set, 8\" (20 cm), Vol. 1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0142\n\nIntended use: for the administration of sterile I.V. fluids to the patient", "code_info": "product code 3C0142, lot numbers GR295287 and GR296418", "firm_fei_number": "1416980", "recalling_firm": "Baxter Healthcare Corp.", "address_1": "Rt. 120 & Wilson Rd", "city": "Round Lake", "state": "IL", "postal_code": "60073", "additional_info_contact": "800-422-9837", "reason_for_recall": "During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.", "root_cause_description": "Employee error", "action": "The firm, Baxter, sent an \"Urgent Product Recall\" letter dated December 6, 2011, via first class mail to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect all locations where their facility's inventory is located for products with the affected lot numbers; return the affected product; request a credit or replacement by calling Baxter Healthcare Center for Service at 1-888-229-0001 between 7:00am to 6:00pm Central time, Monday through Friday; complete and return the attached Customer Reply Form via fax to: 1-847-270-5457, or scan and email to fca@baxter.com; and if they are a dealer, wholesaler, or distributor/reseller that distributed any affected product to other facilities, please notify their customers of this recall.\n\nIf you have any questions regarding the communication, please call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.", "product_quantity": "2,832 units", "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Washington, Wisconsin and West Virginia; and country of: New Zealand.", "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" } } ] }