{ "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": "210426", "product_res_number": "Z-0339-2025", "event_date_initiated": "2024-10-09", "event_date_posted": "2024-11-08", "recall_status": "Open, Classified", "res_event_number": "95499", "product_code": "KPE", "k_numbers": [ "K030888" ], "product_description": "SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.", "code_info": "UDI/DI 00812496011589, Lot Numbers: 66045-A8308, 66045-A8334, 66045-A8360, 66045-A8382, 66045-A8419", "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": "563-556-8800", "reason_for_recall": "A limited number of IV bags have been found to leak during filling.", "root_cause_description": "Under Investigation by firm", "action": "The Metrix Company issued an URGENT: NOTICE OFMEDICAL DEVICE RECALL notice to it consignees on 10/09/2024 via email. The notice explained the issue and requested destruction of all affected product. Distributors were directed to notify their customers. \nFor questions, contact: Demitrianna Soppe, Regulatory Affairs Specialist, The Metrix Company, 4400 Chavenelle Road, Dubuque, IA 52002; Telephone: 563-556-8800; E-mail: recall.coordinator@metrixco.com", "product_quantity": "2921 cases of 50 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, 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" } } ] }