{ "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": "130706", "product_res_number": "Z-0162-2015", "event_date_initiated": "2014-09-26", "event_date_posted": "2014-10-31", "recall_status": "Terminated", "event_date_terminated": "2014-11-19", "res_event_number": "69452", "product_code": "KRA", "k_numbers": [ "K082613" ], "product_description": "Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.", "code_info": "Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 West Merit Parkway", "city": "South Jordan", "state": "UT", "postal_code": "84095", "additional_info_contact": "Cory Marsh\n801-316-3690", "reason_for_recall": "These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.", "root_cause_description": "Mixed-up of materials/components", "action": "Consignees were notified via letter on September 26, 2014. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to US Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account, a representative copy of communications sent directly to their affected accounts, and a copy of the Frequently Asked Questions. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department.", "product_quantity": "56 units", "distribution_pattern": "Nationwide and to India. No govt/military/VA consignees.", "openfda": { "k_number": [ "K142259", "K090870", "K961527", "K954949", "K093750", "K993266", "K211525", "K153502", "K140637", "K790455", "K160884", "K965189", "K180275", "K964868", "K791890", "K181684", "K223176", "K896819", "K182071", "K994155", "K952872", "K140329", "K123477", "K250794", "K082613", "K111263", "K010004", "K020733", "K050630", "K214025", "K071468", "K091559", "K020680", "K052841", "K021591", "K914751", "K060224", "K072724", "K874242", "K260771", "K200582", "K152625", "K173586", "K973645", "K945666", "K002723", "K210838", "K030688", "K955525", "K170931", "K761273", "K905447", "K951502", "K212719", "K932188", "K113289", "K923368", "K801173", "K961668", "K024118", "K130569", "K001966", "K954020", "K811410", "K791844", "K153501", "K100892", "K043538", "K935349", "K230957", "K261610", "K040139", "K932616", "K161801", "K101450", "K082163", "K052738", "K080737", "K082519", "K202318", "K161402", "K210808", "K132947", "K024122", "K033726", 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