{ "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": "159209", "product_res_number": "Z-0076-2018", "event_date_initiated": "2017-09-28", "event_date_created": "2017-11-08", "recall_status": "Terminated", "event_date_terminated": "2018-10-17", "res_event_number": "78331", "product_code": "DWF", "k_numbers": [ "K052081" ], "product_description": "FlexFlow Venous Cannula Model/Catalog Number 200-200\nThe FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch", "code_info": "Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185", "firm_fei_number": "1718850", "recalling_firm": "Sorin Group USA, Inc.", "address_1": "14401 W 65th Way", "city": "Arvada", "state": "CO", "postal_code": "80004-3503", "reason_for_recall": "A specific lot of the FlexFlowTM Venous\nCannula, 200-200, is being recalled because it is sharper or pointier than expected.", "root_cause_description": "Process change control", "action": "LivaNova sent an Urgent Medical Device Recall letter dated September 28 2017, to all affected consignees. The letter instructed customer to isolate products belonging to the lot involved. The level of the effectiveness check is Level A, where 100% of the consignees will be contacted. The customers were requested to send back any affected product and to complete the attached Customer Response Form by fax to 303-467-6502 or by email to USFSN@livanova.com. For questions customers were advised to contact Customer Service at 800-.650-2623.", "product_quantity": "40 units", "distribution_pattern": "Worldwide Distribution - US (nationwide) Internationally to France and Spain", "openfda": { "k_number": [ "K910021", "K884310", "K862190", "K032632", "K874899", "K895352", "K821316", "K143083", "K873212", "K961270", "K832475", "K092509", "K863740", "K120072", "K844138", "K883221", "K081820", "K905312", "K901074", "K863558", "K851323", "K810820", "K881072", "K860988", "K863342", "K874853", "K132995", "K062597", "K870507", "K012617", "K961245", "K150536", "K964195", "K180456", "K902394", "K802261", "K840001", "K861103", "K113459", "K201100", "K113869", "K031037", "K971291", "K090878", "K022174", "K964374", "K831332", "K113411", "K971019", "K152190", "K950814", "K003371", "K972261", "K844139", "K964373", "K060101", "K012774", "K140208", "K875353", "K891576", "K802543", "K133236", "K081560", "K093730", "K941916", "K900753", "K250937", "K123298", 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