{ "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": "167906", "product_res_number": "Z-0365-2019", "event_date_initiated": "2018-09-12", "event_date_posted": "2018-11-02", "recall_status": "Terminated", "event_date_terminated": "2020-11-02", "res_event_number": "81240", "product_code": "KPE", "k_numbers": [ "K900585" ], "product_description": "EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.", "code_info": "Product Code H938739 Lot #'s: 60066021, 60069101, 60072119, 60075857, 60080377, 60084632, and 60095474.  **Update expansion on 02/19/2019 with additional lot numbers: 60070846, 60081688, 60097844, 60098902, 60110761, 60110765, 60120570, 60124005, 60124006, 60124008, 60126009.", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "reason_for_recall": "Potential ability to leak once used for compounding.", "root_cause_description": "Process control", "action": "An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail. Baxter is asking customers to:\n1. Locate and remove all affected product from your facility.\n2. Contact Baxter Healthcare Center for Service to arrange for return and credit.\n3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email.\nNotification Effectiveness: 100%. The non-responding customers will be contacted via telephone.\n\nExpansion on 02/19/2019, Baxter notified customers (and additional customers) of recall and additional lots included.", "product_quantity": "136,800 units", "distribution_pattern": "Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.", "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" } } ] }