{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "193400", "product_res_number": "Z-1240-2022", "event_date_initiated": "2022-05-05", "event_date_created": "2022-06-06", "recall_status": "Open, Classified", "res_event_number": "90103", "product_code": "KRD", "k_numbers": [ "K160219" ], "product_description": "Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)", "code_info": "Lots:\n\n14212811\n14215685\n14212247\n14212812\n14212814\n14215682\n14361413\n14361416\n14285326\n14285328\n14285330\n14297289\n14361412\n14445407\n14444454\n14477949\n14477950\n\n\nUDI:\n\n(01)00827002474994(17)261013(10)14212811\n(01)00827002474994(17)261008(10)14215685\n(01)00827002474987(17)261011(10)14212247\n(01)00827002474987(17)261008(10)14212812\n(01)00827002474994(17)261008(10)14212814\n(01)00827002474994(17)261008(10)14215682\n(01)00827002474994(17)261219(10)14361413\n(01)00827002474994(17)261220(10)14361416\n(01)00827002474987(17)261110(10)14285326\n(01)00827002474987(17)261110(10)14285328\n(01)00827002474994(17)261110(10)14285330\n(01)00827002474994(17)261123(10)14297289\n(01)00827002474987(17)261220(10)14361412\n(01)00827002474987(17)270207(10)14445407\n(01)00827002474994(17)270207(10)14444454\n(01)00827002474987(17)270217(10)14477949\n(01)00827002474994(17)270216(10)14477950", "firm_fei_number": "1820334", "recalling_firm": "Cook Incorporated", "address_1": "750 N Daniels Way", "city": "Bloomington", "state": "IN", "postal_code": "47404-9120", "additional_info_contact": "Cook Medical Customer Relations Department\n800-457-4500", "reason_for_recall": "The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.", "root_cause_description": "Under Investigation by firm", "action": "On May 5, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were advised that the presence of a small stainless steel cannula inside the loading cartridge may go undetected by the user.\n\nCustomers were instructed to examine their inventory and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. Customers should return the product to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Please share this information with appropriate personnel, down to the user level, within your organization or with any organization where the affected devices may have been transferred.\n\nPhysicians should practice their standard patient monitoring following the procedure for an early identification of any complications to mitigate their severity.\n\nIf you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.", "product_quantity": "106,033", "distribution_pattern": "Domestic distribution nationwide. 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