{ "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": "76976", "product_res_number": "Z-0908-2009", "event_date_initiated": "2008-11-24", "event_date_posted": "2009-01-23", "recall_status": "Terminated", "event_date_terminated": "2010-10-22", "res_event_number": "50750", "product_code": "KCY", "product_description": "Expressaire, Disposable Tourniquet Cuff 34\", 2 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and A70107011.\n\nThe tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital).", "code_info": "Lots SO1106, SO2202, SO2227, and SO2232.", "firm_fei_number": "1824206", "recalling_firm": "Virtus, Inc.", "address_1": "1896 Lammers Pike Batesville Commerce Ctr", "city": "Batesville", "state": "IN", "postal_code": "47006", "additional_info_contact": "Tara Collins\n812-933-1121", "reason_for_recall": "The inflation tube may come loose at the connection to the cuff during use.", "root_cause_description": "Employee error", "action": "Sammons Preston was notified of the recall by letter dated 11/24/08, which instructed them to examine their inventory immediately for the specific lot numbers. The quantity on hand should be indicated on the table attached to\nthe letter and the info should be faxed to Virtus at 812-933-0749. Customers that may have tourniquet cuff inventory of identified lot numbers should be contacted. Once recall items have been located in quarantine, Tara Collins, Quality Technician, should be contacted at 812-933-1121 for Return Material Authorization number.", "product_quantity": "2304", "distribution_pattern": "Nationwide Distribution --- including state of Wisconsin.", "openfda": { "k_number": [ "K954201", "K840206", "K910512", "K870784", "K924273", "K925033", "K953953", "K955552", "K112874", "K780988", "K050411", "K954103", "K071140", "K880020", "K841558", "K942303", "K900104", "K162365", "K952038", "K123553", "K202919", "K945167", "K933994", "K791759", "K890014", "K813231", "K871982", "K940615", "K012632", "K842963", "K860095", "K910449", "K853802", "K860463" ], "registration_number": [ "3014830562", "3010595915", "3008264111", "3005173255", "3031700059", "3006128321", "1058584", "2029275", "1822565", "3013783488", "3009750712", "3008381116", "9680215", "9681444", "3033511104", "3014313732", "3015495690", "3015542154", "3006950086", "3016445580", "1421307", "3016678045", "3031887985", "2650143", "1528668", "3006703573", "3007478714", "3004116008", "3023228837", "2011171", "3006975482", "3011277660", "3006535925", "3013846070", "1720929", "3030516433", "9611559", "9680579", "3011642792", "1048735", "3015309643", "3034520", "3005621729", "3010190204", "2184171", "3009350690", "3003244954", "1649518", "1018470", "3010291427", "3014023545", "3009605245", "1220351", "1921846", "3030733800", "3012494290", "3025434447", "3012421607", "3004905643", "3010883047", "1422634", "3004824601", "3007997036", "3002907620", "3014739961", "3032391", "3013730933", "3045058049", "3011683674", "3020163307", "1423537", "1721504", "1043214", "3004727093", "3015280549", "3010410654", "3011185837", "1650907", "3016950436", "3009039068", "1818910", "3030153385", "8010482", "1722028", "3009056984", "9613910", "3016965559", "3016764932", "2032098", "3033589330", "1526350", "3012536737", "8040278", "9611283", "3010759902", "2648666", "3033773618", "3038700849", "3015225571", "3014126909", "8010939", "3005698350", "3010273872", "3015967359", "2320762", "3010123014", "2528981", "3015207155", "3012276218" ], "fei_number": [ "3014830562", "3010595915", "3008264111", "3005173255", "1000219637", "3031700059", "3006128321", "3001236905", "1000117351", "3013783488", "1000203464", "3003350313", "3009750712", "3008381116", "3003040625", "2648209", "3033511104", "3014313732", "1000514656", "3012599796", "3015495690", "3015542154", "3006950086", "3016445580", "1421307", "3016678045", "3031887985", "3006703573", "3007478714", "3004216008", "3004116008", "3023228837", "3003748933", "2011171", "3006975482", "3011277660", "3001236277", "3006535925", "3013846070", "1720929", "3030516433", "1000220733", "1000306431", "3011642792", "1048735", "3015309643", "3005621729", "3010190204", "3009350690", "3003244954", "1018470", "3003058448", "3003255513", "3010291427", "3002681132", "3014023545", "3009605245", "3002808440", "1220351", "1921846", "3030733800", "3012494290", "3025434447", "3012421607", "3004905643", "3004824601", "3001084824", "3007997036", "3002907620", "3014739961", "3013730933", "3045058049", "3011683674", "3020163307", "1721504", "1043214", "3004727093", "3015280549", "3010410654", "1000136409", "3011185837", "3016950436", "3009039068", "1000139815", "1818910", "3004574120", "3030153385", "3009056984", "1000292048", "3016965559", "1526350", "3016764932", "3033589330", "3012536737", "3010759902", "2648666", "3033773618", "3002299608", "3038700849", "3015225571", "3002806816", "3014126909", "3005698350", "3010273872", "3015967359", "3010123014", "2528981", "3015207155", "3012276218" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }