{ "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": "129814", "product_res_number": "Z-0084-2015", "event_date_initiated": "2014-09-16", "event_date_posted": "2014-10-31", "recall_status": "Terminated", "event_date_terminated": "2017-06-21", "res_event_number": "69181", "product_code": "KPE", "k_numbers": [ "K964853" ], "product_description": "Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories.\n\nThe lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.", "code_info": "Product code: 2B8011 Lot Number: UR13D15112", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corp", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter\n847-948-4770", "reason_for_recall": "Particulate matter found inside the fluid path.", "root_cause_description": "Equipment maintenance", "action": "Baxter issued a letter to their consignees stating the following:\n\nBaxter is requesting that you take the following actions:\nAction to be taken if product was purchased directly from Baxter.\n1. Locate and remove all affected product from all locations in your facility\n(the product code and lot numbers can be found on the individual\nproduct package or shipping carton).\n2. Contact Baxter Healthcare Center for Service to arrange for return and\ncredit. The Center for Service can be reached at 888-229-0001\nbetween the hours of 7:00 am and 6:00 pm Central Time. Please have\nyour Baxter eight-digit ship-to account number ready when calling.\n3. Complete the enclosed customer reply form , and return it to Baxter by\neither tax or scanned e-mail.\n4. If you distributed any of the affected products to other facilities, please\nconduct a recall with your end-user customers in accordance with your\ncustomary procedures. Baxter distributed product 2B8011 lot\nU R 13D 15112 to customers between 4/26/2013 and 6/20/2013. Baxter\ndistributed product 2B8013 lot UR13K1 4095 to customers between 11 /27/2013 and 3/ 10/2014.\nAction to be taken if product was received from an alternate source.\n1. Locate and remove all of the affected products from all locations in\nyour facility (the product code and lot numbers can be found on\nthe individual product package or shipping carton).\n2. Contact Baxter Healthcare Center for Service to arrange for return\nand credit. The Center for Service can be reached at 888-229-\n0001 between the hours of 7:00 am and 6:00 pm Central Time.\nPlease have your ship-to account number ready when calling.\n3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.", "product_quantity": "94,224", "distribution_pattern": "Nationwide Distribution including Puerto Rico, and the country of Canada.", "openfda": { "k_number": [ "K813435", "K910936", "K223674", "K982048", "K832247", "K201936", "K820200", "K842628", "K945193", "K871449", "K913608", "K250459", "K854033", "K823538", "K870395", "K061197", "K830232", "K020485", "K820435", "K832254", "K001287", "K810795", "K193528", "K852938", "K902079", "K791774", "K932640", "K812852", "K891077", "K812527", "K844410", "K972464", "K840388", "K974180", "K911576", "K902464", "K850035", "K923448", "K791796", "K842170", "K030888", "K031419", "K251139", "K922214", "K890268", "K844664", "K111217", "K830450", "K840915", "K830299", "K802966", "K852893", "K910673", "K190328", "K983294", "K830193", "K973103", "K880506", "K852777", "K771121", "K932649", "K852778", "K001461", "K041038", "K811233", "K222622", "K870274", "K073538", "K932477", "K890095", "K252079", "K121161", "K870052", "K860042", "K960581", "K926123", "K964853", "K101412", "K190305", "K771228", "K895924", "K811269", "K854034", "K934179", "K210749", "K033916", "K885173", "K843954", "K883400", "K811234", "K782113", "K940258", "K863040", "K090096", "K241442", "K890272", "K854031", "K843523", "K875155", "K771432", "K801652", "K181393", "K252094", "K842629", "K941731", "K844077", "K911567", "K870113", "K760880", "K932641", "K132276", "K811268", "K854032", "K251980", "K041415", "K841597", "K890094" ], "registration_number": [ "3013764800", "3008832845", "3007344957", "9617594", "1420088", "3009128476", "1649518", "1450662", "3013188547", "1054241", "1048735", "3004605321", "3012429465", "2648623", "9710018", "3039404452", "1217831", "2320762", "3030989877", "3013557562", "3030447506", "3002907620", "3016733629", "1928237", "9614854", "9611157", "2032098", "3002807257", "3007143236", "3013517171", "3012809732", "3011270181", "1921846", "3021970868", "9611594", "2031093", "2021236", "1423662", "2184009", "1713468", "1038913", "2025816", "1219103", "3003955307", "3023851856", "3015961073", "3013319212", "1423507", "1037885", "1058584", "3033536319", "3001124136", "3008808123", "1423537", "3015531959", "1937141", "1043214", "9681465", "3004181163", "1643817", "1416980", "9681240", "3011554160", "3015276780", "1047843", "1018470", "1422078", "3004911384", "3044994889", "9617601", "2029275", "3027341532", "9615050", "3014579161", "1055236", "9612052", "2649614", "1036836", "1061927", "3004102635", "2521402", "3013298431", "1223004", "3020778", "3009746061", "3000268902", "3014342658" ], "fei_number": [ "3013764800", "3008832845", "1000219637", "3001236277", "3007344957", "1420088", "3009128476", "1450662", "3013188547", "1048735", "3007033498", "3004605321", "3012429465", "2648623", "1000306431", "3039404452", "1217831", "3030989877", "3013557562", "3030447506", "3002907620", "3016733629", "1928237", "1000116158", "3002807139", "3002534070", "3002807257", "3007143236", "3013517171", "3012809732", "3011270181", "1921846", "3021970868", "2021236", "3008002452", "1713468", "3002806436", "1038913", "3003040625", "3000203000", "3000215273", "2025816", "3003955307", "3023851856", "1000112877", "3015961073", "3013319212", "1037885", "3033536319", "3001124136", "3008808123", "3015531959", "3001236905", "1043214", "1000117446", "3004181163", "1643817", "1416980", "3011554160", "3015276780", "1047843", "1018470", "3003807466", "3002999813", "3004911384", "1000036860", "3044994889", "3003340745", "3003058448", "3027341532", "3014579161", "3003824461", "2649614", "3002806443", "1000148701", "1000112968", "1036836", "3001236549", "1000120555", "3002807113", "3004102635", "2521402", "3013298431", "3020778", "3009746061", "3000268902", "3014342658" ], "device_name": "Container, I.V.", "medical_specialty_description": "General Hospital", "regulation_number": "880.5025", "device_class": "2" } } ] }