{ "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": "43324", "product_res_number": "Z-0906-06", "event_date_initiated": "2005-11-29", "event_date_posted": "2006-05-25", "recall_status": "Terminated", "event_date_terminated": "2006-12-05", "res_event_number": "34243", "product_code": "KPE", "k_numbers": [ "K033916" ], "product_description": "Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions.\nGri-bag 500 ml.", "code_info": "FPB NEP, batch # X-003, code 722842.", "firm_fei_number": "3002807257", "recalling_firm": "Instituto Grifols, S.A.", "address_1": "#2 Can Guasch Street, #2 Can Guasch Street Poligono Levante", "city": "Parets Del Valles Barcelona", "state": "CA", "postal_code": "90032-3520", "country": "Spain", "reason_for_recall": "When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.", "root_cause_description": "Other", "action": "The consignees were notified by phone beginning November 11, 2005. They were requested to return the unused product in exchange for bags from other lot numbers. The returned product will be quarantined at the warehouse. All Gri-bags from batch X-003 will be destroyed.", "product_quantity": "218 units, each unit contains 5 bags.", "distribution_pattern": "Distributed to health care facilities in California, Georgia and Oregon.", "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" } } ] }