{ "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": "139676", "product_res_number": "Z-0229-2016", "event_date_initiated": "2015-08-25", "event_date_posted": "2015-11-05", "recall_status": "Terminated", "event_date_terminated": "2017-04-06", "res_event_number": "72053", "product_code": "LRO", "product_description": "Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.", "code_info": "Lot 25787E, exp. date 1/19/2017", "firm_fei_number": "3004513970", "recalling_firm": "Resource Optimization & Innovation Llc", "address_1": "2909 N Neergard Ave", "city": "Springfield", "state": "MO", "postal_code": "65803", "additional_info_contact": "Wayne H. Flowers\n417-820-2793", "reason_for_recall": "The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.", "root_cause_description": "Component design/selection", "action": "ROi sent a Notice of Correction/Removal letter dated August 25, 2015, to all affected customers. The letter notified customers that ROi recently received notice of a voluntary recall from Edwards Lifesciences regarding their Transducer Kit. ROi also sent an email to their customer on September 25, 2015, informing them of the recall. Attached to the email was the component manufacturer's recall notice and a recall notice from the recalling firm. The recalling firm's recall notice instructed their customer to respond to the notice indicating whether they had any of the recalled product remaining and to destroy any remaining product in their inventory.\r\nFor questions regarding this recall call 417-820-2793.", "product_quantity": "255 packs", "distribution_pattern": "Product was distributed to one customer in Oklahoma.", "openfda": { "k_number": [ "K881083", "K903336", "K971062", "K941846", "K925467", "K931758", "K962826", "K932652", "K950295", "K874760", "K873973", "K902888", "K910365", "K924468", "K854095", "K964921", "K931820", "K902887", "K953083", "K871873", "K882684", "K951149", "K890729", "K030721", "K936117", "K041080", "K854292", "K945831", "K902293", "K970187", "K935483", "K944044", "K935743", "K890098", "K964011", "K922648", "K931824", "K910368", "K950574", "K871437", "K945160", "K905459", "K961863", "K920292", "K935740", "K914174", "K934428", "K871434", "K933137", "K971061", "K932220", "K926269", "K923600", "K913136", "K932221", "K914935", "K952539", "K935858", "K914037", "K884093", "K880961", "K922133", "K871459", "K872448", "K951478", "K885090", "K934029", "K980137", "K914036", "K961683", "K934028", "K935741", "K892389", "K872011", "K883250", "K930270", "K963721", "K905004", "K930700", "K934688", "K931760", "K945481", "K871322", "K920267", "K023276", "K963443", "K963715", "K874439", "K925016", "K925216", "K895202", "K890570", "K890726", "K931759", "K935686", "K965201", "K893814", "K880942", "K970286", "K931673", "K901856", "K213481", "K894685", "K931844", "K932217", "K934030", "K925214", "K842648", "K212258", "K890658" ], "registration_number": [ "3042158935", "3007344957", "3013421458", "3005012805", "3013600605", "3014718111", "3010166880", "1000124971", "2648727", "1055892", "3006540014", "3016096096", "3005246893", "1054241", "1065597", "3004605321", "3004513970", "3011144486", "3005997949", "8022210", "1030451", "2936485", "2029015", "3002669946", "2320762", "3006542380", "3041276890", "3013502418", "3008403546", "1644019", "3010305275", "1928237", "2024980", "3010878085", "3023140882", "1823410", "3004111573", "3008496560", "3006450239", "9614277", "3002807314", "9680425", "1650907", "2024311", "3042480961", "2011171", "3014704068", "3011270181", "3004361903", "1061124", "1921846", "3026197444", "3009750712", "9611594", "8022032", "3006891803", "3006846316", "3005391805", "3009637528", "3015173212", "3012595397", "3007829657", "1721686", "3036002406", "3010452421", "3017636737", "9680143", "3007139365", "3006191977", "3011545608", "1123010", "3011532690", "1527607", "1417592", "3006973666", "3008824097", "3031841433", "3035642068", "9616088", "1610287", "3007329020", "3017467279", "1423537", "3030078769", "1423395", "3012811961", "3007007790", "3011494917", "3006400329", "3011500469", "3043620414", "3044906632", "3014680744", "1043214", "3013960812", "3014421917", "1643817", "3014325891", "3020983482", "3007289408", "3019798849", "1121203", "3011554160", "1066741", "1824619", "9616096", "9681709", "1047843", "3003924117", "3009203853", "3015960676", "3045816907", "1923569", "1018470", "1055954", "3014925393", "3004911384", "3005400762", "3004362278", "3007082897", "3004713352", "3027977504", "3010376936", "1424263", "2029275", "3006271008", "3004519921", "8030672", "3009888344", "3015895045", "3016761372", "1420054", "3011707784", "1063382", "1047429", "1055236", "3005669815", "3006673317", "2433012", "3018071447", "1060680", "3002806603", "3017430544", "3013466775", "9611024", "3015058854", "3018116884", "3013735189", "3009773841", "3013298431", "3004122598", "3003495693", "8030678", "3045857302", "9680357", "1422634", "3018077422", "2431166", "2000028362", "3005595283", "3045816902", "1526711" ], "fei_number": [ "3042158935", "3007344957", "3013421458", "3003015552", "1000123297", "3005012805", "1000160458", "3013600605", "3010166880", "1000124971", "2648727", "3008875470", "3006540014", "3016096096", "3005246893", "3004605321", "3004513970", "3011144486", "3005997949", "1030451", "1000306431", "2936485", "3002669946", "3006542380", "3041276890", "1000117501", "3013502418", "3008403546", "3000215259", "3010305275", "1928237", "3010878085", "3023140882", "1823410", "3004111573", "3008496560", "3006450239", "3002807314", "2024311", "3042480961", "2011171", "3003005156", "3014704068", "3011270181", "3004361903", "2523865", "1000514656", "3002692512", "1921846", "3026197444", "3009750712", "3006891803", "3006846316", "3003803331", "3005391805", "3009637528", "3015173212", "3012595397", "3007829657", "1721686", "3002806436", "3036002406", "3010452421", "3003040625", "3005846326", "3017636737", "3007139365", "3006191977", "3011545608", "3011532690", "1527607", "1417592", "1000112877", "3008824097", "3031841433", "3006973666", "3035642068", "1610287", "3007329020", "3008373372", "3017467279", "3005596530", "3030078769", "3012811961", "3007007790", "1000111202", "3011494917", "3006400329", "3002807170", "3011500469", "3043620414", "3044906632", "3002902735", "3002807308", "3001236905", "3014680744", "3002681132", "1043214", "3013960812", "3014421917", "3932", "1643817", "3014325891", "3020983482", "3007289408", "3019798849", "3011554160", "1000512168", "1824619", "3007596547", "3004829691", "3194", "1047843", "3003924117", "3001717360", "3009203853", "3015960676", "3045816907", "1923569", "1018470", "3000718854", "3014925393", "3004911384", "3005400762", "3004362278", "3007082897", "3004713352", "3027977504", "3010376936", "3006271008", "3009888344", "3015895045", "3016761372", "1420054", "3000717925", "3011707784", "3003807323", "1047429", "3005669815", "1000121355", "2433012", "1000208624", "1000112968", "3018071447", "3002806603", "3017430544", "3013466775", "3015058854", "3018116884", "3013735189", "3009773841", "3013298431", "3004122598", "3003495693", "3002805559", "3045857302", "3018077422", "2000028362", "3005595283", "3045816902", "1526711", "1000113384" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }