{ "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": "189635", "product_res_number": "Z-0219-2022", "event_date_initiated": "2021-10-01", "event_date_created": "2021-11-12", "recall_status": "Open, Classified", "res_event_number": "88821", "product_code": "FGE", "k_numbers": [ "K121125" ], "product_description": "SMART FLEX 8x60 BIL, 80cm\n\nThe S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.", "code_info": "Product Code: SF08060SB; Lot No. 266523", "firm_fei_number": "1016427", "recalling_firm": "Cordis Corporation", "address_1": "14201 NW 60th Ave", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2802", "additional_info_contact": "786-313-2000", "reason_for_recall": "There is a potential for distal tip dislodgement or separation.", "root_cause_description": "Process control", "action": "The firm, Cordis, sent an \"Urgent MEDICAL DEVICE RECALL\" letter dated 10/1/2021 to its consignees/customers:\nIn the US:\nThe letter and Acknowledgement Form was sent to the following two (2) individuals in each account: Materials Director, and Risk Manager. The delivered letter will be followed up as necessary by phone, until signed Acknowledgement is received, or best effort attempt has occurred.\nFor Affiliate countries:\nA copy of the letter sent to the affiliates by email. Reconciliation within the country will be performed by the affiliate. A summary statement that the notification is completed is requested of the affiliate.\n\nConsignees are asked to do the following:\n1) Read the Urgent Medical Device Recall letter.\n2) Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession. If you discover that you do have units from the affected lots in your possession, identify and set aside any units from the identified lots in a manner that ensures the affected product will not be used. Check all storage and usage locations.\n3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to:\nGMB-CordisFieldAction@cardinalhealth.com\n4) Return any affected product to the address listed on the form, with reference to your Customer Number, which is listed on the form.\n5) Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. Maintain awareness of this notice until all affected product has been returned to Cordis.\n6) Keep a copy of this notice with the affected product.\n\nFor any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 1, Monday through F", "product_quantity": "4 units", "distribution_pattern": "US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.", "openfda": { "k_number": [ "K033537", "K012216", "K990808", "K910219", "K033497", "K213946", "K973171", "K901582", "K062264", "K011184", "K130591", "K003793", "K896163", "K954713", "K121832", "K122072", "K050725", "K993145", "K024303", "K072301", "K940965", "K982508", "K955126", "K050698", "K001648", "K963254", "K063733", "K130792", "K170740", "K980290", "K834574", "K242845", "K042204", "K152607", "K873954", "K121430", "K993303", "K003336", "K251291", "K913932", "K010242", "K920361", "K993392", "K030638", "K991929", "K010684", 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