{ "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": 141 } }, "results": [ { "cfres_id": "166933", "product_res_number": "Z-0076-2019", "event_date_initiated": "2018-07-24", "event_date_created": "2018-10-05", "recall_status": "Terminated", "event_date_terminated": "2019-05-17", "res_event_number": "80913", "product_code": "LJT", "k_numbers": [ "K131694" ], "product_description": "BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021\t\nBox of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.", "code_info": "Lot Number: 5363172", "firm_fei_number": "3017892510", "recalling_firm": "Angiodynamics Inc. (Navilyst Medical Inc.)", "address_1": "10 Glens Falls Tech Park", "city": "Glens Falls", "state": "NY", "postal_code": "12801-3864", "additional_info_contact": "SAME\n518-792-4112", "reason_for_recall": "BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled", "root_cause_description": "Unknown/Undetermined by firm", "action": "On July 24, 2018 AngioDynamics initiated this recall action by notifying the affected consignee via telephone call.Per the telephone conversation, the consignee was instructed to segregate the affected device and quarantine the product until further direction from AngioDynamics. A follow-up letter issued dated 7/24/18 email response form to be completed and returned.", "product_quantity": "1 box", "distribution_pattern": "US Nationwide in the state of IN.", "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", 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