{ "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": "75010", "product_res_number": "Z-0632-2009", "event_date_initiated": "2008-10-16", "event_date_posted": "2009-02-06", "recall_status": "Terminated", "event_date_terminated": "2009-08-04", "res_event_number": "50227", "product_code": "DWF", "k_numbers": [ "K063618" ], "product_description": "Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.\n\nThe TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.", "code_info": "Lots 0502199, 0513068, and 0517852.", "firm_fei_number": "1828100", "recalling_firm": "Terumo Cardiovascular Systems Corporation", "address_1": "6200 Jackson Road", "city": "Ann Arbor", "state": "MI", "postal_code": "48103-9586", "additional_info_contact": "800-521-2818", "reason_for_recall": "The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.", "root_cause_description": "Device Design", "action": "An Urgent Medical Device Recall letter dated 10/16/08 was sent to consignees advising them of the problem; requesting that they immediately verify whether or not they had unused cannulae with the affected lot numbers; requesting that they isolate any affected product to prevent use; complete the Customer Response Form, indicate on form if it is medically necessary to use product without introducer; fax Customer Response Form to Terumo CVS at the number listed; and Terumo CVS would contact customers to arrange for the return of unused product. The letter stated that credit would be issued for any unused TenderFlow cannulae that were returned. The quantities to be returned should be indicated on the Customer Response Form. Consignees were advised that, if it was medically necessary to use the affected cannulae, they should be used without the introducer and in accordance with instructions for such use.", "product_quantity": "389 (200 plus 89 samples to US and 100 international)", "distribution_pattern": "Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada.", "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", 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