{
  "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": "110205",
      "product_res_number": "Z-0128-2013",
      "event_date_initiated": "2012-09-25",
      "event_date_posted": "2012-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-08-21",
      "res_event_number": "62315",
      "product_code": "DTQ",
      "k_numbers": [
        "K915183"
      ],
      "product_description": "Perfusion System 8000, base 4 pump, 220V/240V safety monitor included\n\nThe Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.",
      "code_info": "Catalog number: 16405 and serial numbers: 1001-1466",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Rd",
      "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 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction",
      "root_cause_description": "Labeling design",
      "action": "TERUMO sent an URGENT MEDICAL DEVICE letter dated September 25, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed review the Medical Device Recall notice, assure that all users are aware of the notice and place the addendum in the Operator's Manual before page 1.13.  Customers were also instructed to confirm receipt of the Urgent Medical Device letter by faxing, the attached Customer Response Form to 1-800-292-6551.   For questions customers were instructed to call 1-800-521-2818.",
      "product_quantity": "466 units",
      "distribution_pattern": "Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, CALLO PERU, CANADA, CAROLINA PR, CHILE, China, COLOMBIA, Costa Rica, DEKALB, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, Germany, GUAYQUIL ECUADOR, Hong Kong, India, Indonesia, ITALY, Japan, , JARAMA MADRID, Lebanon, LEICESTERSHIRE, MADRID  SPAIN, MADRID SPAIN, Malaysia, MEDLEY, Mexico, D.F., MIAMI, MUMBAI 26 INDIA, MUMBAI, New Zealand, Nicaragua, Pakistan, Panama, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, SELANGOR, MALAYSA, SEOUL, KOREA, Singapore, SOUTH AFRICA, South Korea, Sri Lanka, SWITZERLAND, TAIPEI, TAIWAN, Thailand, TUJUNGA, UNITED ARAB EMIRATES (UAE), URUGUAY, Venezuela, Vietnam, VIGNATE ITALY, WOODDALE, and Yemen.",
      "openfda": {
        "k_number": [
          "K870976",
          "K022947",
          "K221373",
          "K172220",
          "K942582",
          "K091007",
          "K133598",
          "K002116",
          "K915183",
          "K232291",
          "K801097",
          "K842138",
          "K093882",
          "K102726",
          "K822068",
          "K982014",
          "K863541",
          "K851615",
          "K080832",
          "K772001",
          "K163531",
          "K221895",
          "K770002",
          "K813034",
          "K210130",
          "K950990",
          "K871131",
          "K090006",
          "K103762",
          "K173834",
          "K002118",
          "K202125",
          "K070213",
          "K060053",
          "K062396",
          "K071318",
          "K021694",
          "K153376",
          "K020571",
          "K964017",
          "K030141",
          "K862973",
          "K131041",
          "K851614",
          "K011088",
          "K863960",
          "K861388",
          "K943803",
          "K052555",
          "K092463",
          "K151349",
          "K190282"
        ],
        "registration_number": [
          "9611109",
          "3019807891",
          "3002807090",
          "1828100",
          "3011554160",
          "3007427881",
          "8010762",
          "3042990265",
          "3009507273",
          "3010163695",
          "3006073153",
          "3001589655",
          "3010703925",
          "1218444",
          "3005941719",
          "2916596",
          "9680841",
          "2184009"
        ],
        "fei_number": [
          "3010703925",
          "3019807891",
          "1828100",
          "3011554160",
          "3007427881",
          "3009649876",
          "3042990265",
          "3002807111",
          "3009507273",
          "3010163695",
          "3005426550",
          "1000116158",
          "3006073153",
          "3001589655",
          "3006003617",
          "1218444",
          "2916596",
          "3002808267"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}