{ "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": "158552", "product_res_number": "Z-0485-2018", "event_date_initiated": "2017-07-27", "event_date_posted": "2018-01-11", "recall_status": "Terminated", "event_date_terminated": "2020-11-03", "res_event_number": "78042", "product_code": "KPE", "k_numbers": [ "K964853" ], "product_description": "Empty IntraVia Container with Non-DEHP Fluid Path, 500mL\n\nContainers are intended for use in the preparation and administration of drug admixtures.", "code_info": "Product Code 2J8003, Lot No. DR16J18096.", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter\n800-422-9837", "reason_for_recall": "A leak may allow for microbial contamination of the sterile fluid path.", "root_cause_description": "Process control", "action": "US consignees were notified via letter on July 27, 2017 and Canadian consignees were notified on July 31, 2017. Instructions included to locate and remove all affected product from the facility, contact Baxter Healthcare to arrange for return of product, complete and return the Reply Form, and to notify customers if the product was further distributed. For further questions, please call (800) 422-9837.", "product_quantity": "29,088 units", "distribution_pattern": "Distribution in the US and Canada.", "openfda": { "k_number": [ "K782113", "K030888", "K813435", "K941731", "K932641", "K210749", "K923448", "K031419", "K033916", "K875155", "K945193", "K902464", "K902079", "K932649", "K911567", "K854033", "K090096", "K932477", "K811234", "K252079", "K842629", "K251139", "K251980", "K791796", "K241442", "K111217", "K830299", "K811268", "K001287", "K252094", "K940258", "K823538", "K193528", "K771228", "K911576", "K964853", "K223674", "K121161", "K870113", "K041415", "K973103", "K880506", "K841597", "K201936", "K041038", "K840388", "K844077", "K843954", "K190305", "K771432", "K812852", "K801652", "K132276", "K854031", "K222622", "K983294", "K802966", "K843523", "K852778", "K832247", "K844664", "K061197", "K854034", "K860042", "K101412", "K852893", "K852777", "K001461", "K890095", "K890094", "K190328", "K870395", "K895924", "K810795", "K913608", "K885173", "K982048", "K812527", "K832254", "K922214", "K840915", "K883400", "K830232", "K842628", "K771121", "K791774", "K926123", "K250459", "K870274", "K910936", "K852938", "K854032", "K830193", "K073538", "K974180", "K870052", "K811233", "K020485", "K820200", "K842170", "K972464", "K910673", "K934179", "K960581", "K760880", "K830450", "K181393", "K811269", "K890272", "K850035", "K890268", "K820435", "K863040", "K932640", "K891077", "K844410", "K871449" ], "registration_number": [ "3023851856", "3020778", "1058584", "3013298431", "2029275", "1416980", "1423507", "3039404452", "1713468", "3015961073", "1423662", "1047843", "2025816", "3003955307", "2021236", "9611157", "3015531959", "2648623", "2649614", "3007344957", "3015276780", "1223004", "9612052", "3009746061", "3002807257", "3027341532", "9681465", "3004911384", "1219103", "1048735", "3007143236", "1422078", "3004102635", "2184009", "2031093", "1649518", "3021970868", "2521402", "3009128476", "3044994889", "3016733629", "1018470", "1450662", "1061927", "3013319212", "9615050", "1921846", "3030989877", "9710018", "3012429465", "3013517171", "3008808123", "3001124136", "3011270181", "3002907620", "9617601", "3012809732", "1423537", "1043214", "9617594", "1038913", "9611594", "3014342658", "3008832845", "3013557562", "1037885", "1420088", "3004181163", "3030447506", "3013188547", "1055236", "3004605321", "2032098", "1036836", "1643817", "1937141", "3013764800", "3011554160", "3000268902", "1928237", "1217831", "9681240", "9614854", "3033536319", "1054241", "2320762", "3014579161" ], "fei_number": [ "1000116158", "3023851856", "3002807139", "1000219637", "3020778", "3001236905", "3013298431", "1416980", "3039404452", "3002999813", "1713468", "3015961073", "3003040625", "1047843", "2025816", "3003955307", "2021236", "3007033498", "3015531959", "2648623", "2649614", "3007344957", "3015276780", "3009746061", "3001236277", "1000120555", "3002807257", "3027341532", "3001236549", "1000306431", "3004911384", "1048735", "3007143236", "3003824461", "3004102635", "3003340745", "3021970868", "2521402", "1000117446", "3009128476", "3044994889", "3016733629", "1018470", "1450662", "3003058448", "3013319212", "1921846", "3030989877", "3008002452", "3012429465", "3013517171", "3008808123", "3001124136", "1000036860", "3011270181", "3002907620", "3012809732", "3002534070", "3002806443", "1043214", "1000112968", "1038913", "3000215273", "3014342658", "3008832845", "3013557562", "1037885", "1420088", "3030447506", "3004181163", "3000203000", "3013188547", "3004605321", "1000112877", "1036836", "1643817", "3013764800", "3011554160", "3000268902", "1928237", "1217831", "3002807113", "3033536319", "3014579161", "3003807466", "3002806436", "1000148701" ], "device_name": "Container, I.V.", "medical_specialty_description": "General Hospital", "regulation_number": "880.5025", "device_class": "2" } } ] }