{ "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": "177443", "product_res_number": "Z-0344-2020", "event_date_initiated": "2019-10-24", "event_date_created": "2019-11-06", "recall_status": "Terminated", "event_date_terminated": "2020-06-24", "res_event_number": "84165", "product_code": "LRO", "product_description": "Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG\nCode: DT11955", "code_info": "Lot/Batch Number: 2019052190 Exp Date: 5/31/2024", "firm_fei_number": "3008403546", "recalling_firm": "Centurion Medical Products Corporation", "address_1": "100 Centurion Way", "city": "Williamston", "state": "MI", "postal_code": "48895-9086", "reason_for_recall": "Sterile packaging incomplete seals may compromise sterility of the product", "root_cause_description": "Process control", "action": "Centurion medical issued notification was emailed to the affected distributor on October 24, 2019, Centurion's parent company, Med line Industries. Centurion mailed a letter to the single affected medical facility on 10/24/19, via certified mail, return receipt. The letter provides reason for recall, heath risk and action to take: be accessed for use.\n(1) Identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use\n2) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required.\n3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed.\n\nQuestions Contact Director of Quality Assurance, Centurion Medical Products Corporation\n(517) 546-5400 Ext.1122", "product_quantity": "80 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K930270", "K964011", "K041080", "K963715", "K970187", "K935858", "K931824", "K930700", "K963443", "K935686", "K920292", "K933137", "K023276", "K925214", "K936117", "K961863", "K885090", "K873973", "K895202", "K934028", "K871322", "K934428", "K952539", "K880961", "K920267", "K884093", "K914935", "K854292", "K931673", "K212258", "K945481", "K925216", "K931760", "K910365", "K874439", "K902888", "K871437", "K935740", "K932220", "K935483", "K934688", "K932221", "K030721", "K962826", "K874760", "K941846", "K882684", "K890726", "K926269", "K950574", "K931844", "K901856", "K951149", "K961683", "K965201", "K980137", "K953083", "K945160", "K932217", "K922648", "K854095", "K934030", "K922133", "K934029", "K871459", "K890098", "K931820", "K924468", "K872011", "K872448", "K871873", "K914036", "K944044", "K842648", "K914037", "K905004", "K925467", "K971062", "K883250", "K914174", "K880942", "K945831", "K932652", "K893814", "K871434", "K935741", "K951478", "K910368", "K213481", "K902293", "K931759", "K894685", "K881083", "K903336", "K931758", "K971061", "K935743", "K923600", "K925016", "K902887", "K890570", "K950295", "K905459", "K890729", "K964921", "K970286", "K892389", "K963721", "K913136", "K890658" ], "registration_number": [ "9681709", "3005595283", "3007829657", "2029015", "1060680", "3013298431", "2029275", "9680357", "3010376936", "1055954", "1417592", "3009637528", "3007007790", "3014325891", "3009750712", "1047429", "3013466775", "1527607", "3006891803", "1047843", "3012811961", "3006271008", "3006540014", "1123010", "3006400329", "3014421917", "8030672", "3011707784", "8022032", "3002807314", "3041276890", "3010878085", "3006673317", "9616096", "3007344957", "1526711", "3042480961", "3019798849", "1063382", "3042158935", "2936485", "3006846316", "2011171", "3013735189", "2024311", "3012595397", "1721686", "3010166880", "3008824097", "1610287", "3004519921", "3045857302", "2433012", "2648727", "1823410", "3004111573", "3004911384", "3045816907", "3005400762", "3017467279", "3014680744", "3018071447", "3006191977", "3005391805", "3013421458", "3007082897", "1423395", "9616088", "3017430544", "8030678", "1018470", "3007139365", "9680143", "1644019", "3023140882", "3004122598", "1065597", "2024980", "3017636737", "1921846", "3036002406", "3031841433", "3020983482", "3006450239", "1000124971", "3010452421", "3015960676", "3004513970", "3014925393", "3016761372", "3008496560", "3002669946", "3014704068", "3018116884", "3004713352", "1422634", "3009203853", "3011270181", "9680425", "3005669815", "1423537", "1043214", "3006973666", "3013960812", "3003495693", "3015895045", "3018077422", "3011144486", "3010305275", "3026197444", "1424263", "3009773841", "1066741", "3013600605", "8022210", "9611594", "3015173212", "1061124", "1923569", "3045816902", "3004361903", "1650907", "3014718111", "9611024", "3007289408", "3008403546", "1055236", "3004605321", "3007329020", "3005997949", "1643817", "3009888344", "9614277", "1420054", "1030451", "3011532690", "3043620414", "3011554160", "1824619", "1121203", "3013502418", "1928237", "3006542380", "3004362278", "3035642068", "3003924117", "1055892", "3011494917", "3015058854", "3002806603", "3011545608", "3044906632", "1054241", "3005012805", "2320762", "3011500469", "2431166", "3005246893", "3030078769", "3016096096", "2000028362", "3027977504" ], "fei_number": [ "3005595283", "3007829657", "3002902735", "3001236905", "3013298431", "3010376936", "1000208624", "1417592", "3009637528", "3007007790", "3014325891", "3009750712", "1047429", "3013466775", "1527607", "3003040625", "3006891803", "1047843", "1000514656", "3012811961", "3006271008", "3005596530", "3006540014", "3006400329", "3014421917", "3011707784", "3005846326", "3002807314", "1000117501", "3002807170", "3041276890", "3010878085", "3003803331", "3007344957", "1526711", "3042480961", "3019798849", "3042158935", "2936485", "3006846316", "2011171", "3013735189", "2024311", "3001717360", "3012595397", "3007596547", "2523865", "1721686", "3010166880", "3008824097", "1610287", "3045857302", "3003807323", "2433012", "2648727", "1000111202", "1000306431", "1823410", "3004111573", "3004911384", "3045816907", "3005400762", "3017467279", "3014680744", "3018071447", "3006191977", "3005391805", "3013421458", "3007082897", "1000121355", "3002805559", "3017430544", "1018470", "3007139365", "3023140882", "3002681132", "1000113384", "3004122598", "3017636737", "3008373372", "1921846", "3036002406", "3020983482", "3031841433", "3006450239", "1000124971", "3010452421", "3015960676", "1000160458", "3004513970", "3014925393", "3016761372", "3008496560", "3002669946", "3014704068", "3018116884", "3002807308", "3008875470", "3004713352", "3009203853", "3011270181", "3005669815", "1000123297", "3194", "1043214", "3006973666", "3013960812", "3003495693", "1000112968", "3015895045", "3018077422", "3011144486", "3010305275", "3026197444", "3009773841", "3000718854", "1000512168", "3013600605", "3003005156", "3015173212", "3004829691", "1923569", "3045816902", "3004361903", "3007289408", "3000717925", "3008403546", "3004605321", "1000112877", "3007329020", "3005997949", "1643817", "3009888344", "1420054", "1030451", "3011532690", "3043620414", "3011554160", "1824619", "3932", "3013502418", "3003015552", "1928237", "3006542380", "3004362278", "3035642068", "3003924117", "3011494917", "3015058854", "3002806603", "3011545608", "3044906632", "3000215259", "3005012805", "3011500469", "3002692512", "3005246893", "3030078769", "3016096096", "3002806436", "2000028362", "3027977504" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }