{ "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": "176404", "product_res_number": "Z-0007-2020", "event_date_initiated": "2018-09-21", "event_date_created": "2019-10-01", "recall_status": "Open, Classified", "res_event_number": "83509", "product_code": "KPE", "k_numbers": [ "K960581" ], "product_description": "ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.", "code_info": "Lot Numbers: H938901 63615-A1768, H938901 63615-A1770, H938901 63615-A1772, H938901 63615-A2648, H938901 63615-A2650, H938901 63615-A2652, H938901 63615-A2653, H938901 63615-A2654, H938901 63615-A2656, H938901 63615-A2658, H938901 63615-A2660, H938901 63615-A2662, H938901 63615-A3951, H938901 63615- A3953, H938901 63615-A3955, H938901 63615-A3958, H938901 63615-A3960, H938901 63615-A3962, H938901 63615-A3964, H938901 63615-A3966, H938901 63615-A3967, H938901 63615-A5337, H938901 63615-A5339, H938901 63615-A5341, H938901 63615-A5343, H938901 63615-A5345, H938901 63615-A5347, H938901 63615-A5349", "firm_fei_number": "1000117446", "recalling_firm": "The Metrix Company", "address_1": "4400 Chavenelle Rd", "city": "Dubuque", "state": "IA", "postal_code": "52002-2655", "additional_info_contact": "Dave Wagner\n800-752-3148", "reason_for_recall": "Potential for leaking product", "root_cause_description": "Process control", "action": "The Metrix Company notified the direct account (distributors) by telephone on 09/21/2019. The firm asked if the consignees received any complaints of leaking during the divider rod removal and return of any of the lot.\n\nThe firm expanded the recall and disseminated the notices by email and telephone on 08/2/30/2019. Press was issued on 09/09/2019.", "product_quantity": "175392 bags", "distribution_pattern": "US Nationwide distribution including the states of PA, MA, IL CA.", "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" } } ] }