{ "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": 7 } }, "results": [ { "cfres_id": "49934", "product_res_number": "Z-0377-2007", "event_date_initiated": "2007-01-05", "event_date_posted": "2007-01-25", "recall_status": "Terminated", "event_date_terminated": "2008-05-01", "res_event_number": "37115", "product_code": "FED", "k_numbers": [ "K043418" ], "product_description": "Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.", "code_info": "Lot U1546391.", "firm_fei_number": "1825146", "recalling_firm": "Cook Urological, Inc.", "address_1": "1100 W Morgan St", "city": "Spencer", "state": "IN", "postal_code": "47460-9426", "additional_info_contact": "812-829-4891", "reason_for_recall": "Lack of assurance of sterility, as the packages may not have been sealed.", "root_cause_description": "Other", "action": "Consignees were notified via recall letter dated 1/5/07 and requested to return the product.", "product_quantity": "4", "distribution_pattern": "Massachusetts, Maine, New Hampshire and Puerto Rico.", "openfda": { "k_number": [ "K942573", "K230801", "K252572", "K250695", "K191067", "K123675", "K990775", "K251599", "K102485", "K072405", "K203119", "K123013", "K903842", "K190030", "K841258", "K051504", "K082102", "K230748", "K160861", "K150083", "K133359", "K250585", "K243025", "K092221", "K120126", "K230752", "K122649", "K912265", "K050253", "K140523", "K243710", "K171208", "K023902", "K810180", "K122270", "K983415", "K203165", "K092156", "K260965", "K030438", "K240853", "K220065", "K211301", "K082589", "K100081", "K061324", "K110531", "K151084", "K172575", "K250517", "K161110", "K260521", "K890629", "K002018", "K182520", "K233472", "K162205", "K250132", "K043418", "K140323", "K033954", "K240167", "K261915", "K151801", 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