{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150003", "product_res_number": "Z-0364-2017", "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": "Covidien Devon Light Glove packaged in sterile surgical kits\nReference: 31140208\n\nProduct Usage:\nA disposable, sterile, single-use cover for compatible surgical light handles", "code_info": "All lot codes in the following kits: Item Number Decription 56479\t7335-SMC DELIVERY KIT 573208\t7519-DHCG SURGI-START KIT 573210\t7581-CSD SURGI-START KIT 573310\t7417-SSC SURGI-START KIT 573326\t7497-HLS MINI-PLUS KIT 573328\t7437-NRF SURGI FOOTPACK ASCKIT 573343\t7499-88 SURGICAL KIT 573346\t7499-TLG SURGICAL KIT 573359\t7499-HLW MINI-PLUS KIT 573368\t7494-CAB2 SURGICAL KIT 573370\t7411-SSI MINI PLUS KIT 573509\t7696-GSL-VL SINGLE BASIN KIT 573529\t7697-T4E SINGLE BASIN SURGI KI 573558\t7665-CPB SINGLE BASIN KIT 573561\t7696-KSC SINGLE BASIN KIT 573713\t7553-SBT MINI-PLUS KIT 573732\t7620-CWA SURGICAL ASC KIT 573741\t7667-HMI SURGICAL ASC KIT 573776\t7520-BHP SURGICAL ASC KITS 573777\t7527-BHB SURGICAL ASC KITS 573798\t7496-8KB MINI-PLUS KIT 573799\t7516-UNIKB SET-UP KIT 573813\t7590-GHF HAND AND FOOT PACK 773501\t7692-WIW2 SURGI-START KIT 773701\t7600-ESC SURGI-START KIT 31140208\t3611 FLEXBL LITE GLOVE 1EA/PKG 31140216\t3613 LITE GLV-FLEXIBLE 3EA/PKG 31140257\t3612 LITE GLV-FLEXIBLE 2EA/PKG 31141479\tK-1842-S STD. MINI-KIT STERILE 31141487\tK-1560-S3 STD. MINI KIT STER. 31141495\tK-1530-S3 STANDARD MINI-KIT 31141537\tK-1940-S STD. MINI KIT STER. 31141552\tK-1920-S STANDARD MINI-KIT 31141560\tK-1200-S3 STD MINI-KIT 31141578\tK-1840-S STD. MINI KIT STER. 31131141602\tK-1630-S STD. MINI KIT STER. 31141610\tK-1615-S STD. MINI KIT STER. 31141628\tK-1614-S STD MINI-KIT 31141651\tK-1560-S STD. MINI KIT STERILE 31141669\tK-1530-S STD. MINI KIT 31141677\tK-1200-S STD. MINI KIT 31141784\tK-1960-S STANDARD MINI-KIT 31141859\tK-1615-S3 STD MINI-KIT 31141875\tK-1940-S3 STD. MINI-KIT STER. 31144507\t7519 BUNNY KIT - GENERAL BUNNY 31144879\t7815 SURGI-START KIT STERILE 31144895\t7614-T4 SURGI-START KIT 31144960\t7693-T4 SURGI-START KIT 31144978\t7766 SURGI-START KIT 31145025\t7496-8 MINI-PLUS KIT - STERILE 31145215\t7896 STANDARD SURGI-START KIT 31145231\t7897 STD, SURGI-START KIT 31145249\t7897-T8 SURGI-START KIT STER 31145298\t7896-T8 STANDARD,SURGI START 31145363\t7496-88 STANDARD,MINI-PLUS KIT 31145397\t7497-8 STANDARD MINI PLUS KIT 31145413\t7497-88 STANDARD,MINI-PLUS KIT 31145496\t7696-T4 STANDARD SURGI-START 31145504\t7708 STANDARD SURGI-START KIT 31145520\t7614 SURGI-START KIT STERILE 31145546\t7693 SURGI-START KIT STERILE 31145629\t7696 STANDARD SURGI-START KIT 31145645\t7608 SURGI START KIT STERILE 31149720\t7496-NNB VAR. MINI PLUS KIT 31150470\t7496-PUP VAR. MINI PLUS KIT 31152302\t7896-NNB VAR. SURGI-START KIT 31153060\t7697-T4 SURGI-START KIT 31153938\t7756-KST VAR.SURGI-START KIT 31154266\t7656-KST VAR. SURGI-START KIT 31175089\t7497-8T6 STD MINI-KIT PLUS 31175105\t7553-NAL VARIATION BUNNY KIT 41586\tK-1660-S STD. MINI-KIT STER. 31314720\t7514-CCS VARIATION BUNNY KIT\t\t 31321097\t7697 STD SURGI-START KIT\t\t 31324299\t7830-HOH STD PLUS SURGI-START\t\t 31361234\t7460-CNR2 MINI-PLUS KIT STD KT\t\t 31404851\tBIRTHDAY KIT STANDARD PLUS\t\t 31451092\t7600-DNV SURGI-START KIT STD\t\t 31451480\t7493-SFW MINI-PLUS KIT STD\t\t 31453098\t7682-MHP SURGI-START STD PLUS\t\t 31457131\t7461-SMS MINI-PLUS KIT STD PLU\t\t 31460432\t7596-SHH STD PLUS BUNNY KIT\t\t 50000148\tK-1920-COE MINI-KT STAND-PLUS\t\t 50000510\t7500-END STANDARD SURGICAL KIT\t\t 50000511\t7516-UNI STANDARD SURGICAL KIT\t\t 50000512\t7557-UNI UNIVERSAL SURGICAL KT\t\t 50000515\t7667-BRT SURGI-START KIT STRD.\t\t 50000568\t7605-SEC SURGI STANDARD PLUS K\t\t 50000599\t7694-ADA SURGI-START KIT\t\t 50000947\t7413-CAD MINI-PLUS KIT\t\t 50000980\t7897-SME SURGI-START KIT\t\t 50001029\t7417-PCP MINI-PLUS KIT\t\t 50001033\t7520-FSF MINOR KIT\t\t 50001052\t7427-CFS MINI-PLUS KIT\t\t 50001057\t7484-HHS MINI-PLUS KIT\t\t 50007698\t7698-T4 STANDARD SURGI-START K\t\t 50007699\t7699-T4 STANDARD SURGI-STAR\t\t 50007898\t7898-T8 STANDARD SURGI-START K\t\t 50007899\t7899-T8 STANDARD SURGI-START K\t\t 50047403\t7496-HCS MINI-PLUS KIT\t\t 50047405\t7496-HES MINI-PLUS KIT\t\t 52000076E\tC-SECTION PACK\t\t 52000082E\tDELIVERY KIT\t\t 573375A\tMINI-PLUS KIT\t\t 573830D\tMINOR KIT\t\t 573831B\tMAJOR KIT", "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": "13,786,893 in total Distributed in USA", "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": [ "K212258", "K934028", "K951149", "K894685", "K871873", "K963721", "K883250", "K890098", "K932217", "K881083", "K945160", "K962826", "K933137", "K920292", "K965201", "K884093", "K873973", "K923600", "K936117", "K910368", "K854292", "K934428", "K971062", "K871459", "K953083", "K041080", "K931759", "K874760", "K971061", "K890729", "K880961", "K930700", "K905459", "K023276", "K902293", "K935686", "K964921", "K931673", 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"2320762", "3006450239", "3013421458", "3026197444", "1060680", "3003495693", "3014325891", "3015173212", "3015058854", "3042158935", "3043620414", "3007139365", "3004513970", "3031841433", "3015895045", "3004362278", "3017430544", "3005246893", "9616088", "3011500469", "8022032", "3006271008", "1923569", "3035642068", "3004361903", "3013600605", "3042480961", "3020983482", "1123010", "1424263", "3045816907", "1423395", "1065597", "1422634", "1055236", "3006400329", "9611594", "3013735189", "3016761372", "3005400762", "3045857302", "1047429", "2000028362", "3007289408", "3006540014", "3004111573", "1643817", "1823410", "3010878085", "3007007790", "1063382", "3013466775", "3006846316", "3006542380", "1030451", "3004122598", "3010305275", "3006891803", "2431166", "1043214", "9680143", "1650907", "9680425", "1644019", "2648727", "3012811961", "9614277", "3002806603", "3016096096", "3036002406", "3014718111", "3011494917", "3018116884", "3011545608", "3019798849", "3009637528", "3027977504", "3014704068", "3013298431", "3003924117", "3002669946", "8022210", "3044906632", "1417592", "1921846", "3008403546", "3007829657", "3008824097", "1928237", "8030672", "1061124", "3011532690", "1824619", "2433012", "2029015", "3010376936", "2011171", "3030078769", "2024980", "1721686", "3011707784", "1000124971", "3017636737", "1610287", "9611024", "3011270181", "3010452421", "3005595283", "3006973666", "3041276890", "3007344957", "1055954", "1526711", "1047843", "8030678", "3009888344", "3013960812", "1527607", "1420054", "3011144486", "3002807314", "1423537", "3018077422", "2936485", "3045816902", "9681709", "3015960676", "3023140882", "3014421917", "9616096", "3011554160", "3005669815", "3018071447", "1121203", "3009773841", "1018470", "1066741", "3004713352", "3005997949", "3009750712", "3010166880", "3004605321", "2029275", "3017467279", "9680357", "3004519921", "3006673317", "3005391805", "3009203853" ], "fei_number": [ "3008496560", "3006191977", "2024311", 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