{ "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": "150071", "product_res_number": "Z-0366-2017", "event_date_initiated": "2016-09-29", "event_date_created": "2016-11-08", "recall_status": "Terminated", "event_date_terminated": "2019-04-05", "res_event_number": "75302", "product_code": "LRO", "product_description": "Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove \nItem Number Description\n380789003 SURE SET SINGLE BASIN PACK\n400383006 MAJOR BASIN PACK\n400383007 MAJOR BASIN PACK\n618275004 BASIN PACK\n\nProduct Usage:\nA disposable, sterile, single-use cover for compatible surgical light handles", "code_info": "All lot codes in the following:  Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK", "firm_fei_number": "1219930", "recalling_firm": "Covidien LLC", "address_1": "60 Middletown Ave", "city": "North Haven", "state": "CT", "postal_code": "06473-3908", "additional_info_contact": "SAME\n203-492-5000", "reason_for_recall": "Added Instructions for Use: After application, inspect the Light Glove for barrier integrity", "root_cause_description": "Process control", "action": "Medtronic issued a Correction Notice on September 29, 2016. Customers were notified via Federal Express and the letter informed customers of the addition of the following statement to the Instructions for Use (IFU): After application, inspect the Light Glove for barrier integrity. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 962-9888", "product_quantity": "4950 units", "distribution_pattern": "Worldwide Distribution - US Nationwide\nForeign:\nCanada:\nAndorra\nAustria\nBelgium\nCzech Republic\nDenmark\nFinland\nFrance\nGermany\nGreece\nIreland\nIsrael\nItaly\nLatvia\nLuxembourg\nMonaco\nNetherlands\nNorway\nPoland\nPortugal\nRussian Federation \nSaudi Arabia\nSlovenia\nSouth Africa\nSpain\nSweden\nSwitzerland\nUnited Arab Emirates\nUnited Kingdom", "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" } } ] }