{ "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": "112483", "product_res_number": "Z-0050-2013", "event_date_initiated": "2012-09-25", "event_date_posted": "2012-10-11", "recall_status": "Terminated", "event_date_terminated": "2014-01-15", "res_event_number": "63079", "product_code": "KFM", "k_numbers": [ "K882758" ], "product_description": "Battery, 220V (Includes charger and connecting cable)\n\nThe Sarns\" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.", "code_info": "Catalog number: 9491; and lot numbers: 1001-1187, 1101, 1193-1286, 2083-2085, 2018, 2288, 2289, 2447-2451, 2634, 2635, and 2884.", "firm_fei_number": "1828100", "recalling_firm": "Terumo Cardiovascular Systems Corporation", "address_1": "6200 Jackson Road", "city": "Ann Arbor", "state": "MI", "postal_code": "48103-9586", "additional_info_contact": "734-741-6173", "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various\nmalfunctions of the battery backup system for the Sarns\" Centrifugal System.\nThe reports can be broadly categorized as follows:\n\" Failure to charge\n\" Failure to hold charge\n\" Failure to operate\n\nIn the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In", "root_cause_description": "Component design/selection", "action": "TERUMO sent an Urgent Medical Device Recall letter dated June 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. On 09/25/2012 an URGENT MEDICAL DEVICE RECALL notification and addendum was sent to all consignees. \n\nTCS issued this notification as a Safety Advisory to alert all users of the Sarns centrifugal system of the potential for malfunction and remind them to review the appropriate sections of the Operators Manual for the Sarns Delphin Battery. Providing an addendum to the Operators Manual for the Sarns Delphin Battery with additional instruction on the use and charging of a discharged battery.\n\nCustomers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; place the addendum in the Operator's Manual; and confirm receipt of the communication by faxing or emailing the attached Customer Response Form.\nFor questions customers were instructed to call 1-800-521-2818.\nFor questions regarding this recall call 734-741-6173.", "product_quantity": "289 units", "distribution_pattern": "Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, VA, WA, WI, and WV. Puerto Rico and internationally to:\n\nALEXANDRIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CENTRO AMERICA, CHILE, COLOMBIA, Dominican Republic, Ecuador, FRANCE, GERMANY, GREECE, Guatamala, HOLLAND, HONG KONG, India, ITALY, Japan, KL SEGUNDO, KOREA, LEICESTERSHIRE, MALAYSA, Malaysia, Mexico, Mexico, Mexico, NETHERLANDS, Panama, Peru, Philippines, RALEIGH, Republic of Georgia, SANTIAGO CHILE, Saudi Arabia, SEOUL KOREA, SHANGHAI, CHINA, Singapore, South Africa, SPAIN, SWITZERLAND, TAIWAN, Thailand, UNITED ARAB EMIRATES (UAE), Uruguay, USA, and Venezuela,", "openfda": { "k_number": [ "K962981", "K011835", "K973011", "K061072", "K082321", "K111657", "K090515", "K073631", "K921550", "K913176", "K030462", "K013393", "K854975", "K110493", "K250326", "K110845", "K232132", "K030154", "K770937", "K032040", "K991864", "K952879", "K842007", "K191077", "K050109", "K103357", "K012325", "K063723", "K093801", "K111658", "K894255", "K012209", "K900601", "K992592", "K852698", "K080470", "K020998", "K111384", "K112229", "K915547", "K882129", "K882758", "K170029", "K902404", "K884659", "K100631", "K051209", "K200091", "K080774", "K201068", "K780953", "K192850", "K020529", "K902198", "K915363", "K943861", "K201320", "K193663", "K183623", "K023132", "K133265", "K933014", "K983272", "K050890", "K132712", "K111972", "K020271", "K903925", "K090051", "K972740", "K852807", "K251762", "K851613", "K083111", "K033270", "K991783", "K912604", "K220842", "K031300", "K233091", "K083794", "K190650", "K202169", "K851855" ], "registration_number": [ "2029275", "1828100", "3030125051", "3009507273", "3010163695", "1218444", "9681834", "3044156918", "2011171", "1124841", "3009380063", "3005941719", "2916596", "3012119238", "2184009", "3011554160", "3007427881", "3006849754", "3008792657", "3014990448", "1319639", "2528981", "8010026", "1422634", "3019807891", "3002807090", "1123137", "3003661577", "3016746283", "1928237", "3006073153", "1220648", "8010762", "3003306248", "9680841", "9617601" ], "fei_number": [ "1828100", "3002534070", "3030125051", "1000138054", "3009507273", "3010163695", "3005426550", "3002808327", "1218444", "3044156918", "2011171", "1000123180", "1000514656", "3009380063", "2916596", "3012119238", "3011554160", "1000306431", "3007427881", "3009649876", "3006849754", "3002807111", "3008792657", "3014990448", "2528981", "2828", "3019807891", "3003661577", "3016746283", "1928237", "1000116158", "3006073153", "1220648", "3000204839", "3006003617", "3003306248" ], "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4360", "device_class": "2" } } ] }