{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197361", "product_res_number": "Z-0925-2023", "event_date_initiated": "2022-09-16", "event_date_posted": "2023-01-07", "recall_status": "Open, Classified", "res_event_number": "91276", "product_code": "LHI", "k_numbers": [ "K173577" ], "product_description": "Prep-Fill Guarded Luer Connector (GLC): \n\na. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile;\n\nb. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile;\n\nc. Part number 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile;\n\nd. Part number 57-402, Female Slip - Female Lock Guarded Luer Connector, Sterile; and\n\ne. Part number 57-403, Female Slip - Female Slip Guarded Luer Connector.", "code_info": "a. Part 57-400 - Lot numbers 45266, 44549, 44120, 43800, 43626, 42634, 42236, 39350, 37176, 36596, 33074. UDI: B212574001.\n\nb. Part 57-400W - Lot numbers 39371, 37093, 37086, 37079, 39378, 39364, 39357, 36558. UDI: B21257400W1.\n\nc. Part 57-401 - Lot numbers 45047, 43633. UDI: B212574011.\n\nd. Part 57-402 - Lot number 37151. UDI: B212574021.", "firm_fei_number": "1217831", "recalling_firm": "International Medical Industries, Inc.", "address_1": "2981 Gateway Dr", "city": "Pompano Beach", "state": "FL", "postal_code": "33069-4326", "additional_info_contact": "954-917-9570 Ext. 222", "reason_for_recall": "Blister package had an unsealed edge compromising sterility.", "root_cause_description": "Process control", "action": "The recalling firm issued undated \"URGENT: MEDICAL DEVICE RECALL\" letters via email on 9/16/2022 informing the consignee of the reason for recall, risk to health, and actions to be taken by the customer/user, which included the following:\n\nActions to be taken by the Customer/User:\nDo not use the lots and have all identified product be returned. Please identify the number of devices by lot, complete the table on page two, return this completed form via email to Sfoott@imiweb.com . IMI will contact you to arrange for return or destruction of the product.\n\nActions to be taken by Distributors:\nDo not use the lots and have all identified product to be returned. Notify your customers and if your customers are not end users (such as another medical device distributor or supply company) they must notify their customers to the end user level.\nPlease identify the number of devices by lot, complete the table on page two, return this completed form via email to Sfoott.@imiweb.com .\n\nActions to be taken by Kitters/Re-packagers:\nDo not use the lots and have all identified product to be returned. Please identify the number of devices by lot, return this completed form via email. IMI will contact you to arrange for return or destruction of the product.\n\nShipping/reconciliation Method Information: IMI's preferred method to address affected inventory is to return the product directly to IMI regardless of business or customer affiliation to IMI.\n\nAfter receiving a report on a second lot, the firm expanded the recall to include all unexpired lots. A recall letter was issued on 11/17/2022 via email and was similar to the initial recall letter except that it included additional part numbers and lot numbers.\n\nIf you have any questions, call IMI, Inc. at 954-917-9570 ext222.", "product_quantity": "228,000 DEVICES", "distribution_pattern": "US Nationwide Distribution was made to AR, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, MD, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, PA, SC, TX, and VA. There was no government/military/foreign distribution.", "openfda": { "k_number": [ "K243404", "K002705", "K022523", "K844340", "K904855", "K926071", "K203674", "K212445", "K890205", "K160503", "K050339", "K860595", "K955594", "K251715", "K060866", "K051669", "K072511", "K012189", "K963583", "K844904", "K923966", "K052790", "K832312", "K001368", "K923782", "K120150", "K233284", "K910213", "K902853", "K820937", "K090634", "K983794", "K090905", "K950305", "K033682", "K222718", "K961008", "K860113", "K904225", "K171796", "K955595", "K843639", "K013087", "K070584", "K943181", "K861434", "K133097", "K212525", "K860703", "K850757", "K092782", "K850051", "K240748", "K901063", "K162216", "K896990", "K090917", "K853830", "K062482", "K151963", "K220856", "K013523", "K140402", "K251676", "K230988", "K240940", "K842345", "K102590", "K031861", "K924064", "K955398", "K943095", "K233021", "K083851", "K905201", "K853075", "K955622", "K100640", "K040456", "K202732", "K905116", "K151423", "K994323", "K110023", "K132040", "K212530", "K040634", "K980381", "K092246", "K894827", "K241976", "K970359", "K200893", "K093182", "K170095", "K935274", "K955896", "K000367", "K243985", "K003730", "K884626", "K122265", "K150787", "K243486", "K832332", "K041232", "K260301", "K142600", "K192154", "K120424", "K830836", "K964989", "K972134", "K890204", "K001293", "K231071", "K201469", "K910793", "K900585", "K140442", "K173577", "K913804", "K010703", "K120384", "K201415", "K111577", "K834500", "K832347", "K252987", "K121182", "K042410", "K041222", "K900865", "K080976", "K023747", "K213513", "K854556", "K233287", "K921365", "K853188", "K132863", "K001831", "K041691", "K970789", "K902482", "K852882", "K190149", "K830970", "K133602", "K872446", "K980587", "K182819", "K091389", "K043304", "K935532", "K925401", "K023539", "K101940", "K161800", "K024239", "K990711", "K860610", "K812928", "K072759", "K010623", "K140730", "K895922", "K250345", "K071741", "K913985", "K853212", "K232875", "K974431", "K190816", "K912771", "K860434", "K921031", "K172884", "K901404", "K080174", "K232055", "K131646", "K232987", "K852467", "K082752", "K240761", "K041564", "K101309", "K083152", "K972117", "K974198", "K172631", "K973654", "K183187", "K920015", "K960466", "K152441", "K130179", "K854008", "K874495", "K932462", "K963012", "K230464", "K960921", "K903159", "K092318" ], "registration_number": [ "3015531959", "3004911384", "1720929", "3003704957", "3014312726", "2022435", "9710643", "3013234390", "3012494290", "3003974574", "8031007", "1055927", "3007880912", "2032112", "3009340644", "1047843", "2030598", "3003768277", "2245590", "3030626857", "3044026004", "2953359", "3007014520", "1833470", "9616066", "9610847", "3013298431", "3006571738", "3009265194", "3030447506", "3027645738", "3012798826", "2950467", "3008810357", "3030446844", "3012429465", "1048735", "3004201393", "2016945", "2521402", "3006946348", "3017406698", "1420088", "3013820501", "1424263", "1416980", "8020347", "9615908", "3010659131", "3002907620", "3011554160", "9614279", "3045751639", "3011392709", "3012410077", "3030201489", "3016418550", "3014579161", "3023851856", "1061124", "1223004", "3015488952", "9617604", "3043226252", "1056553", "3013319212", "2649614", "3009756327", "1724474", "3004194523", "2650143", "2245270", "9681240", "1423662", "3010512490", "3008824097", "3007681502", "3007143236", "1319639", "3010329663", "3003965134", "1526863", "3003678543", "3005042488", "9614854", "3022555290", "9615050", "1530671", "1058584", "3010291427", "3005245797", "3014342658", "3009631669", "3005053560", "2024024", "9611665", "3012302888", "3008717264", "3015085713", "9613744", "3038356900", "3045322464", "3000279201", "3006979803", "1643817", "3015276780", "3018503755", "9617594", "1417592", "3003152976", "3013481097", "1720734", "8021083", "3013557562", "3016938816", "3013561817", "3010160527", "3011802635", "3006610642", "3000223297", "9681819", "3016566166", "2520313", "1526534", "1450662", "1319660", "2025816", "1037885", "3015972753", "3004548776", "3008729892", "3007221462", "9612052", "3001124136", "2245304", "9616567", "2011171", "3033527281", "2032098", "9610825", "1713468", "1410248", "3002808227", "1423507", "3007829657", "3018125942", "3002807257", "1000632857", "1835568", "3015176617", "1035907", "3007649127", "2523676", "3014936217", "1928237", "1314417", "1019003", "1217831", "2244478", "3010432890", "3002682307", "3017636737", "3005941719", "9611157", "3020417125", "3042177665", "3003674698", "3020706315", "3013764800", "1018470", "3013445787", "2030624", "3013188547", "2029275", "1061927", "9710018" ], "fei_number": [ "3015531959", "3004911384", "1720929", "1000113359", "1000138054", "3003704957", "3000215205", "2022435", "3000203000", "3014312726", "3003340745", "3013234390", "3012494290", "3003974574", "3007880912", "3007033498", "3009340644", "1047843", "2245590", "3044026004", "3030626857", "3007014520", "3005612924", "1000306431", "3003058448", "3013298431", "3006571738", "1000512168", "1000518731", "3009265194", "3030447506", "3002999813", "3027645738", "3012798826", "3008810357", "3030446844", "3008002452", "3012429465", "1048735", "3002806469", "3004201393", "2016945", "2521402", "1000120555", "3003807466", "3006946348", "3002771638", "3017406698", "1420088", "3013820501", "3001639729", "1416980", "3010659131", "3002907620", "3011554160", "3045751639", "3011392709", "3012410077", "3030201489", "3016418550", "3014579161", "3023851856", "5637", "3002808169", "3015488952", "3003282181", "3002963732", "3043226252", "3002807555", "3013319212", "2649614", "3004194523", "2245270", "3010512490", "3000215273", "3003094851", "3008824097", "3007681502", "3007143236", "3010329663", "3003965134", "1526863", "3003678543", "3005042488", "3002807111", "3000206435", "3022555290", "3002710954", "3000327333", "3010291427", "3005245797", "3014342658", "3009631669", "3005053560", "2024024", "3012302888", "3008717264", "3015085713", "1000123689", "3038356900", "3003076831", "3003824461", "3045322464", "3000279201", "3006979803", "1000136478", "1000219637", "1643817", "3015276780", "3018503755", "1417592", "3003152976", "3013481097", "1720734", "3013557562", "3016938816", "1000132370", "3013561817", "3003767881", "3011802635", "3006610642", "3000223297", "3016566166", "2520313", "1526534", "1450662", "2025816", "3002807880", "3002879021", "1037885", "3015972753", "3004548776", "3003015552", "3007221462", "2245304", "3001124136", "2648209", "2011171", "3002807040", "3033527281", "1713468", "1410248", "3002808227", "3007829657", "3018125942", "3002807139", "1000632857", "3002807257", "3002806443", "3002558692", "3002783962", "3015176617", "1035907", "3007649127", "2523676", "3014936217", "1928237", "3001237677", "1314417", "1019003", "1217831", "1000136269", "1000115518", "3010432890", "3000147578", "3002807095", "3002682307", "3017636737", "3020417125", "3042177665", "3003674698", "3013764800", "1018470", "3013445787", "3013188547", "3002807038" ], "device_name": "Set, I.V. Fluid Transfer", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }