{ "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": "32595", "product_res_number": "Z-0909-04", "event_date_initiated": "2004-01-13", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2010-08-30", "res_event_number": "28840", "product_code": "FGE", "k_numbers": [ "K032137" ], "product_description": "This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCULAR Cat. No. Lot No. Use By. The inner pouch is similarly labled.", "code_info": "DSPROD\t 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"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": "Hal Delgado\n786-313-2108", "reason_for_recall": "Air may be introduced into this Stent system when used with certain size acessory devices.", "root_cause_description": "Other", "action": "On Jan. 13, 2004 Cordis initiated Sales Representative visits to accounts to provide enhanced Instructions for Use to prevent the air introduction problem which was followed by a Recall Letter to each account providing corrective Instructions for Use on March 29, 2004. Another letter issued on May 4, 2004 recalling the earlier March 29, 2004 letter and modified Instructions for Use, instructing consignees/physicians to only use the device in the biliary tree or liver as indicated in the lableling.", "product_quantity": "7815", "distribution_pattern": "Product was distributed to 415 domestic hospital accounts nationwide and to two related international distributores in Isreal and the Netherlands.", "openfda": { "k_number": [ "K851956", "K112543", "K980191", "K913932", "K990592", "K993588", "K821817", "K003450", "K912122", "K033497", "K024303", "K844384", "K020682", "K980372", "K014007", "K900904", "K920236", "K910493", "K072301", "K002650", "K000564", "K210419", "K963397", "K032530", "K003186", "K823428", "K974815", "K910671", "K000550", "K041796", "K033134", "K924608", "K083627", "K992318", "K990854", "K896504", "K042518", "K021630", "K152524", "K894871", "K033834", "K032457", "K965147", "K892383", "K033212", "K251123", "K014205", "K963691", 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