{ "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": "35078", "product_res_number": "Z-0256-05", "event_date_initiated": "2004-09-20", "event_date_posted": "2004-11-24", "recall_status": "Terminated", "event_date_terminated": "2005-03-01", "res_event_number": "30048", "product_code": "LJT", "k_numbers": [ "K953529" ], "product_description": "LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray is then sterilized. The primary sterile barrier is the inner sealed tray.", "code_info": "Catalog #LPS 7255, Lot #20474", "firm_fei_number": "3017892510", "recalling_firm": "Horizon Medical Products Inc", "address_1": "1 Horizon Way", "city": "Manchester", "state": "GA", "postal_code": "31816-1749", "additional_info_contact": "Mary Gossard, M.S\n800-782-9330", "reason_for_recall": "The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.", "root_cause_description": "Other", "action": "Consignees were notified by letter on 09/20/2004.", "product_quantity": "44 kits", "distribution_pattern": "FL, GA, LA, MD, NJ, OK, TX, VA", "openfda": { "k_number": [ "K870950", "K905842", "K875213", "K033686", "K964066", "K934802", "K022983", "K964538", "K260916", "K881075", "K994196", "K030636", "K122767", "K093414", "K190559", "K952537", "K973497", "K905851", "K952548", "K953529", "K070003", "K153359", "K871209", "K840481", "K915273", "K895871", "K953254", "K854019", "K921475", "K841150", "K090512", "K934518", "K953571", "K930206", "K924748", "K832917", "K091099", "K992880", "K153238", "K850888", "K896093", "K942623", "K934640", "K070116", "K881745", "K932095", "K921379", "K122834", "K863305", "K133335", "K832788", "K932841", "K934792", "K922896", "K032600", "K926011", "K905845", "K903691", "K924505", "K081472", "K974471", "K903364", "K952435", "K881342", "K934520", "K000125", "K081425", "K953073", "K151239", "K993024", "K952748", "K993860", "K964559", "K873213", "K942412", "K905841", "K994111", "K951872", "K122899", "K830730", "K994216", "K925373", "K073210", "K150514", "K050310", "K032008", "K932010", "K935767", "K961580", "K905850", "K873735", "K110424", "K932671", "K132177", "K050176", "K934167", "K961652", "K962751", "K954258", "K963684", "K232737", "K932840", "K971582", "K911355", "K951873", "K010767", "K923019", "K922419", "K905838", "K030083", "K002770", "K862018", "K181446", "K882230", "K942103", "K872838", "K933990", "K912702", "K932509", "K950131", "K942848", "K021580", "K841679", "K131694", "K924250", "K955819", "K942024", "K974829", "K905847", "K031282", "K010426", "K853322", "K870817", "K992697", "K921201", "K910005", "K920036", "K881256", "K932411", "K982888", "K942784", "K905843", "K961583", "K890518", "K082126", "K912423", "K974475", "K851293", "K951875", "K034065", "K904417", "K931748", "K251253", "K842355", "K062414", "K951076", "K875214", "K840788", "K973862", "K950212", "K921902", "K913350", "K071993", "K880297", "K951814", "K912540", "K905844", "K933316", "K934573", "K870187", "K841149", "K874184", "K150733", "K081889", "K853827", "K070911", "K991897", "K073423", "K870886", "K912424", "K953017", "K872898", "K122402", "K895030", "K871192", "K905848", "K072481", "K140169", "K933350", "K955407", "K903220", "K861498", "K905839", "K954433", "K905849", "K853332", "K983480", "K032557", "K905852", "K955587", "K945551", "K970442", "K072549", "K063377", "K910448", "K911449", "K101017", "K031844", "K961615", "K953110", "K933986", "K872329", "K043178", "K061424", "K870519", "K954297", "K033473", "K945752", "K962695", "K830000", "K072215", "K870260", "K905646", "K872149", "K894650", "K120281", "K960572", "K880571", "K891611", "K901722", "K932447", "K863750", "K880305", "K864349", "K951874", "K080645", "K882190", "K934796", "K974533", "K946189", "K003006", "K905846", "K032754", "K252478", "K141146", "K823838", "K945250", "K951077", "K895689", "K112713", "K936012", "K912465", "K922434", "K911055", "K022110", "K010189", "K922147", "K850967", "K905840", "K130576", "K853981", "K060812", "K102385", "K971140", "K875276", "K863296", "K873575", "K863723", "K934504", "K962230", "K032375", "K964117", "K901419", "K242328", "K072657", "K081311", "K864446", "K904077", "K893460", "K111101", "K960350", "K032044", "K153228", "K130923", "K926139", "K982507", "K110407", "K060036" ], "registration_number": [ "", "1319211", "3008537309", "3009888344", "3012494290", "1220905", "3007939342", "2245270", "3013666218", "3011534620", "3010149039", "3015859709", "3018094310", "3026560514", "2011171", "9617592", "3006260740", "1222928", "3042205359", "1061124", "3013750125", "1450392", "1048735", "9617604", "3006425876", "1000393132", "3010041511", "1219930", "3011237770", "2032112", "1018233", "3005704822", "3003700453", "2030624", "3007156625", "8020785", "1319639", "2518902", "2025816", "3013557562", "2246552", "9681202", "3015531529", "1223004", "9680794", "3004407880", "3009746061", "3006082230", "9611665", "3005232773", "3006942524", "3003678543", "3015537049", "3003915875", "3011088743", "1820334", "9612452", "1000523114" ], "fei_number": [ "", "1319211", "3008537309", "3009888344", "3012494290", "3003076831", "1000138054", "1220905", "3007939342", "2245270", "3013666218", "3011534620", "3010149039", "3015859709", "3018094310", "3026560514", "2011171", "3006260740", "3002468371", "3002806713", "3042205359", "3013750125", "1450392", "1048735", "3006425876", "1000393132", "1000120555", "3010041511", "1219930", "3011237770", "1018233", "3005704822", "3003700453", "1000512168", "3008737795", "3003737899", "2518902", "2025816", "3013557562", "2246552", "3015531529", "3002807095", "3004407880", "3009746061", "3009291251", "3006082230", "3005232773", "3006942524", "3003678543", "3015537049", "3003915875", "3011088743", "3002558692", "1820334", "1000120613", "3008133910", "3000206435", "1000523114" ], "device_name": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "medical_specialty_description": "General Hospital", "regulation_number": "880.5965", "device_class": "2" } } ] }