{ "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": "104918", "product_res_number": "Z-0533-2012", "event_date_initiated": "2011-01-09", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-12-26", "res_event_number": "57863", "product_code": "KDT", "product_description": "H & W Research Kit, Product A1776, each kit packed in a bag or envelope. 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. \n\nBlood specimen collection", "code_info": "All kits containing Triad alcohol prep pads", "firm_fei_number": "1000118383", "recalling_firm": "Heritage Labs International LLC", "address_1": "560 N Rogers Rd", "city": "Olathe", "state": "KS", "postal_code": "66062-1211", "additional_info_contact": "Vicki Harbarger\n913-764-1045", "reason_for_recall": "Kits contain recalled Triad alcohol pads", "root_cause_description": "Material/Component Contamination", "action": "Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on \"as needed\" basis. \nUpon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. \nUsers are to use the replacement wipes instead of the wipes contained in the kits. \nFor any questions call (888)764-4120.", "product_quantity": "25 kits", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Germany", "openfda": { "k_number": [ "K800946", "K834579", "K834412", "K823773", "K770071", "K862665", "K873593", "K811793", "K820246", "K821621", "K822870", "K833660" ], "registration_number": [ "", "3027605742", "3018015381", "1917413", "1220502", "3017063217", "3036773433", "2029275", "3017450368", "3024933340", "3006795808", "1417592", "3011966385", "3041276591", "2242368", "2436875", "3031582434", "3011676045", "3044883001", "3003890648", "3015505238", "3014827316", "3021169869", "3009526936", "3010781643", "3014662855", "3003207991", "3022897868", "3013530901", "9617475", "3002732769", "3012422258", "9681465", "3009407607", "3016710934", "3004111573", "3016741564", "8010932", "3021013122", "9616088", "3004941127", "9680143", "3004122598", "3010384323", "1623486", "3008573567", "1921846", "3018779125", "3003646592", "3013517171", "3014150341", "3017059592", "3012494290", "1000484830", "3026062723", "2245437", "3001124136", "3014022295", "3016837106", "3004824601", "1222773", "3045058049", "3002444944", "1531062", "1423537", "3044466317", "1043214", "3009963993", "9615395", "1836161", "2013736", "3010131137", "1524213", "9613662", "3021186226", "3009732568", "3015173212", "1061124", "3013557562", "3005271071", "8030607", "2243072", "3016994953", "1055236", "2016673", "1036836", "1930987", "3016904853", "3002945499", "1030451", "2916657", "3006795767", "1063851", "1932015", "3006210673", "3044150131", "3020831613", "3006897996", "3007583567", "3006542380", "3011649813", "3017390965", "3035642068", "9617032", "2025606", "2244900", "3010407203", "1054241", "3038276119", "2320762", "3010420046", "3017262662", "3013894805", "3010194621", "3008236846" ], "fei_number": [ "", "3027605742", "3018015381", "3002902735", "1917413", "3001236905", "1220502", "3017063217", "3002808075", "3036773433", "3017450368", "3024933340", "3006795808", "1417592", "3011966385", "3041276591", "2242368", "1000120768", "3003040625", "3031582434", "3011676045", "3044883001", "3003890648", "3015505238", "3014827316", "3021169869", "3009526936", "3010781643", "3014662855", "1000442352", "3003207991", "3013530901", "3002732769", "3002750084", "3012422258", "1000521444", "1000306431", "3009407607", "3016710934", "3006509795", "3004111573", "3016741564", "3002919051", "3021013122", "3004941127", "3004122598", "3010384323", "1623486", "3008573567", "1921846", "3018779125", "3003646592", "3013517171", "3014150341", "3017059592", "3012494290", "1000484830", "3026062723", "3002807308", "2245437", "3001124136", "3014022295", "3016837106", "3004824601", "3045058049", "3002444944", "3044466317", "1043214", "3009963993", "1000112968", "2013736", "3010131137", "1524213", "3002806485", "1000512168", "3021186226", "3009732568", "3015173212", "3013557562", "3005271071", "3002768455", "3017876253", "2243072", "3016994953", "1000112877", "2016673", "1036836", "1930987", "3016904853", "3002945499", "1030451", "2916657", "3006795767", "3005246281", "3006210673", "3044150131", "3020831613", "3006897996", "3007583567", "3006542380", "3011649813", "3017390965", "3002807113", "3035642068", "2025606", "2244900", "3010407203", "3038276119", "1000118260", "3010420046", "3017262662", "3013894805", "3010194621", "3008236846", "3002807393" ], "device_name": "Container, Specimen Mailer And Storage, Sterile", "medical_specialty_description": "Pathology", "regulation_number": "864.3250", "device_class": "1" } } ] }