{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "25116", "product_res_number": "Z-0298-03", "event_date_initiated": "2002-11-07", "event_date_posted": "2003-04-03", "recall_status": "Terminated", "event_date_terminated": "2015-08-06", "res_event_number": "25078", "product_code": "DTR", "k_numbers": [ "K000977" ], "product_description": "Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .", "code_info": "TCVS Product code number 0006-00011; all coils in custom cardiovascular procedure kits within their labeled shelf life of 24 months (i.e. kits made 12/1/2000 to 10/25/2002) as follows: Procedure Kit Codes Produced in Lot\tLot # 63182-02\t CA02 70035; 8539TX\t CA07 62973; 63153;63688-01; 8539TX\t CA14 63688-01\t CA14T 62973\t CA28 8539TX\t CC04 63688-01; 8525T\t CC11 63688-01\t CC11T 63688-01\t CC11TR 62786; 62973;63432; 70060; 63688-01 CC18 63688-01\t CC18T 63323-02; 63153\t CC25 62336-01; 7957-02; 8525T\t CD04 63323-02\t CD11 70035 ;8539TX;\t CD18 63182-02; 8525T\t CD25 62417-03; 62973-01; 63182-02; 63688-01 CE01 63688-01\t CE01R 62973-01; 63688-01\t CE01T 70187; 62786\t CE08 70017; 62973-01 ;63182-02; 63688-01 CE15 63182-02; 63688-01\t CE15T 63688-01\t CE15TR 70001; 63182-02\t CE22 63323-02 \t CE29 63432; 62336-01; 63079-01; 8525T; 63070-01;  63182-02\t CF06 131246-01; 63014-01; 63688-01 CF13 63688-01\t CF13R 63688-01 \t CF13T 70001; 63182-02\t CF20 63323-02\t CF28 63064 ;62336-01; 62544-01\t CG03 63153; 70035; 62973-01\t CG10 63064; 62417-03; 62973-01; 63688-01 CG17 63064\t CG17R 63079-01; 63688-01\t CG24 62336-01 \t CH01 62786; 63432;62973-01; 63688-01\t CH08 62973-01 \t CH08T 70035; 63323-03; 63688-01\t CH15 70001; 63688-01; 63182-02\t CH22 63688-01\t CH22T 63064; 70001; 70251; 131246-01; 63014-01\tCH29 64130; 62544-01; 62973-01\t CK05 64130\t CK12 64130\t CK12T 64130; 63079-01\t CK19 63014-01; 63323-03\t CK26 70085\t CL03 62973-01; 8539TXC\t CL09 64203; 62973-01; 63064-01\t CL16 70413; 8525T\t CL23 63298\t YP04 62417-03\t YP11 62336-01\t YP18 63014; 8539TX\t ZA08 62973 ;8539TX\t ZA22 62973; 63079\t ZA29 63432\t ZC05 62973; 63014; 63432; 62513-01\t ZC12 63014; 63079; 63298; 62973\t ZC19 63153 ;63315; 63432; 62361-02; 62513-01\tZC26 62513-01\t ZC26T 62786; 63315; 63323\t ZD05 63064; 63323; 62544-01; 8525T; 62513-01\tZD12 62361-02; 62544-01; 63323\t ZD19 63014 ;8539T; 62786\t ZD26 62786; 63315\t ZE02 63014; 63064; 63432; 8525T\t ZE09 63153; 62544-01; 63323\t ZE16 62973 ;63323\t ZE23 63014\t ZE30 63064; 62417-03\t ZF07 63064\t ZF07R 62786; 63153\t ZF14 62544-01; 8539TX\t ZF21 8539TX\t ZF21T 8539TX\t ZF21TR 62973; 63014; 63298\t ZF29 62973; 63432; 63315-01\tZG04 62973; 8539TX\t ZG11 63323; 63079-01\t ZG18 63323\t ZG18T 62973; 63070; 63432; 62417-03; 63315-01\tZG25 63688; 70001; 63315-01; 8335TX\tZH09 62973; 63688; 63079-01; 63153\tZH16 63688; 70001; 62336-01; 8525T\tZH23 63688; 70001\t ZH23T 63688; 63726; 8539TX\t ZH30 63688\t ZH30R 63688\t ZK06 63688\t ZK06T 70012\t ZK20 63014\t ZK20R 70012\t ZK20T 62786; 63079-01; 8525T; 8539TX\tZK27 8539TX\t ZK27R 62786; 62973; 63014; 62417-03; 63323-01\tZL04 63014\t ZL04R 62973\t ZL04T 63014\t ZL10 63014\t ZL10T 8539TX; 8525T\t ZL17 62544-01; 63323-01; 8525T ZL24 63323-01\t ZL24T 70073\t ZM08 62786\t ZM15 62786; 62417-03; 8525T ZM22 63014; 63688; 70085; 62336-01;\tZM29 70085\t ZM29R 62973; 63153; 63432; 63688\tZN05 62973\t ZN05T 62973\t ZN05TR 8539TX\t ZN12 8525T \t ZN19 62417-03; 62544-01\t ZN26 62336-01 ;8525T; 63182-02 ZP03 8525T; 63182-02\t ZP03T 63064; 63751;63815\t ZP10 70106; 63182-02\t ZP17", "firm_fei_number": "1000149028", "recalling_firm": "Terumo Cardiovascular Systems Corp", "address_1": "28 Howe St", "city": "Ashland", "state": "MA", "postal_code": "01721-1305", "additional_info_contact": "Terri Brinsfield\n800-262-3304", "reason_for_recall": "Heat exchanger may contain loose particulate matter", "root_cause_description": "Other", "action": "Terumo Cardiovascular Systems notified customers by telephone on 11/8/02 by telephone, fax, and mail to advise distributors and end-users to cease use of the Heat Coil.. A follow-up letter issued to the accounts with instructions for the return of product.", "product_quantity": "10035", "distribution_pattern": "Nationwide.\nAR, CA, OH, FL, GA, IN, LA, MN, NJ, PA, TN, TX, WA, WI", "openfda": { "k_number": [ "K003724", "K802848", "K032068", "K200438", "K790756", "K853791", "K871774", "K833555", "K861102", "K910923", "K880451", "K012898", "K896807", "K883332", "K000977", "K240190", "K923311", "K223879", "K781210", "K812093", "K905568", "K991137", "K962320", "K934355", "K900640", "K041979", "K833662", "K811204", "K250150", "K252541", "K953838", "K802879", "K791430", "K982467", "K883330", "K090555", "K873561", "K162958", "K884560", "K201984", "K212688", "K850794", "K072583", "K931967", "K913077", "K220110", "K843983", "K964571", "K860920", "K973475", "K880663", "K040355", "K896020", "K852780", "K173716", "K840045", "K770018", "K800717", "K832417", "K944219", "K853516", "K883071", "K162774", "K853410", "K913691", "K840256", "K021830", "K860523", "K883439", "K925369", "K944267", "K020106", "K831157", "K081838", "K905500", "K823451", "K240908", "K770016", "K932251", "K904171", "K802545", "K883331", "K781764", "K813264", "K772117", "K914742", "K823533", "K770017", "K897039", "K800377", "K870804" ], "registration_number": [ "3044156918", "9681834", "3019807891", "1625519", "3016746283", "3030125051", "1319639", "3002807090", "1124841", "1724474", "1643817", "3003752502", "9680841", "1928237", "3010163695", "8010762", "8010026", "3011554160", "3015136750", "2916596", "9617601", "3017987980", "3006073153", "2011171", "1218444", "3013267343", "1649914", "3010155661", "2029275", "3005941719", "2184009", "1721676", "3002806603" ], "fei_number": [ "3044156918", "3019807891", "3002534070", "3009649876", "1625519", "3016746283", "3030125051", "1643817", "3003752502", "3000204839", "1000116158", "1928237", "3010163695", "3003094851", "3006003617", "2828", "3011554160", "3015136750", "1000138054", "2916596", "3017987980", "3006073153", "2011171", "1218444", "3013267343", "3002807111", "3010155661", "1000306431", "3002808327", "3005426550", "3001665800", "1721676", "3002806603" ], "device_name": "Heat-Exchanger, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4240", "device_class": "2" } } ] }