{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 14 } }, "results": [ { "cfres_id": "163711", "product_res_number": "Z-1760-2018", "event_date_initiated": "2018-02-08", "event_date_created": "2018-05-09", "recall_status": "Completed", "res_event_number": "79841", "product_code": "LJT", "k_numbers": [ "K063377" ], "product_description": "POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362", "code_info": "Lot Number\tUnique Device Identifier (UDI) REAN0063\t(01)00801741110726(17)170628(10)REAN0063 REAN1123\t(01)00801741110726(17)170628(10)REAN1123 REAP0467\t(01)00801741110726(17)170728(10)REAP0467 REAY1733\t(01)00801741110726(17)180331(10)REAY1733 REBS1266\t(01)00801741110726(17)180731(10)REBS1266 REBV1731\t(01)00801741110726(17)181231(10)REBV1731 REBX1626\t(01)00801741110726(17)190331(10)REBX1626 REBY0777\t(01)00801741110726(17)190430(10)REBY0777", "firm_fei_number": "2020394", "recalling_firm": "Bard Peripheral Vascular Inc", "address_1": "1625 W 3rd St Bldg 1 1625 W 3rd St", "address_2": "Bldg 1", "city": "Tempe", "state": "AZ", "postal_code": "85281-2438", "reason_for_recall": "The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.", "root_cause_description": "Error in labeling", "action": "The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions:\n\"Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions.\n\nFor any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice.\n\nEnclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet.\"", "product_quantity": "359 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K032044", "K982507", "K905849", "K951077", "K932509", "K140169", "K870950", "K871192", "K873213", "K043178", "K922896", "K070116", "K932841", "K934167", "K895030", "K926011", "K952537", "K071993", "K960350", "K072481", "K081472", "K862018", "K963684", "K962695", "K830000", "K953017", "K110407", "K955819", "K870817", "K912424", "K933316", "K964538", "K252478", "K934573", "K950131", "K260916", "K934792", "K932411", "K970442", "K873735", "K133335", "K953571", "K070003", "K933990", "K153238", "K832788", "K073210", "K022110", "K881745", "K870886", "K930206", "K905848", "K141146", "K942784", "K081311", "K964559", "K120281", "K063377", "K911449", "K905850", "K952748", "K932010", "K091099", "K904417", "K942412", "K132177", "K080645", 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"K962751", "K951814", "K992697", "K032375", "K003006", "K912465", "K050310", "K072657", "K934640", "K863750", "K130923", "K151239", "K954297", "K842355", "K881342", "K872838", "K954433", "K953529", "K893460", "K870519", "K921201", "K895689", "K912540", "K913350", "K971140", "K933350", "K050176", "K953110", "K854019", "K851293", "K961583", "K891611", "K961580", "K150514", "K954258", "K882190", "K903691", "K863305", "K936012", "K072549", "K034065", "K923019", "K942623", "K875276", "K932447", "K905842", "K922147", "K002770", "K922434", "K904077", "K991897", "K952435", "K952548", "K974829", "K905843", "K934518", "K921902", "K880305", "K072215", "K832917", "K993024", "K946189", "K081425", "K010189", "K122834", "K905646", "K130576", "K922419", "K073423", "K122899", "K841679", "K874184", "K905841", "K081889", "K961652", "K890518", "K864349", "K911355", "K905845", "K920036", "K934520", "K932671", "K896093", "K905846", "K992880", "K872149", "K850888", "K000125", "K880297", "K010767", "K921379", "K910448", "K982888", "K090512", "K903220", "K030636", "K242328", "K153359", "K841149", "K935767", "K912702", "K110424", "K955587", "K875213", "K111101", "K871209", "K863296", "K905840", "K993860", "K070911", "K951873", "K101017", "K850967", "K905852", "K032008", "K994111", "K905847", "K062414", "K853981", "K905844", "K945250", "K881075", "K951076", "K823838", "K895871", "K953073", "K905851", "K960572", "K122767", "K951875" ], "device_name": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "medical_specialty_description": "General Hospital", "regulation_number": "880.5965", "device_class": "2", "registration_number": [ "2030624", "1000523114", "3009746061", "3013557562", "3015537049", "3007156625", "9611665", "1061124", "2518902", "1820334", "2246552", "3009888344", "3010149039", "1219930", "3005704822", "3026560514", "1048735", "9680794", "3012494290", "3004407880", "3011534620", "8020785", "3047514279", "9612452", "3018094310", "1319639", "3005232773", "3006425876", 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