{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "106244",
      "product_res_number": "Z-0802-2013",
      "event_date_initiated": "2010-11-01",
      "event_date_posted": "2013-02-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-11-08",
      "res_event_number": "60695",
      "product_code": "DRY",
      "product_description": "Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.",
      "code_info": "Catalog number: 101 and Serial Numbers: 0503, 1000, 1017, 1070, 1071, 1073, 1074, 1076, 1077, 1080, 1082, 1083, 1107-1110, 1115-1117,1124,1126-1134, 1136, 1137, 1139-1146, 1148-1152, 1154-1156, 1159-1162, 1164-1166, 1168-1177, 1182, 1185-1190, 1192,1193, 1195, 1197, 1198, 1225, 1228, 1229, 1237, 1239-1241,1243-1245,1247, 1249-1326, 1332-1339, 1344-1347, 1349, 1350-1363, 1365-1409, 1411-1436,1438, 1440-1447, 1449-1453, 1455-1463,1465-1482,1484-1492,1494-1552,1555-1565, 1567-1600,1602,1605-1607,1609-1611,1613-1623,1625-1629,1632-1651,1653, 1655-1660, 1662-1664, 1666, 1667,1669-1679,1681-1684,1686,1689-1691, 1693-1710,1712-1715,1717-1750,1752-1757,1759-1771,1773-1785,1787,1788,1790-1809, 1811-1831,1833,1838,1839,1855-1858,1866, and TK001-TK011.",
      "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": "Inaccurate readings.  Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.",
      "root_cause_description": "Software design",
      "action": "Terumo sent an \"URGENT MEDICAL DEVICE CORRECTION\" letter dated November 1, 2010 to all affected customers.  The letter identified the product, problem, and the actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions or concerns.",
      "product_quantity": "622 units",
      "distribution_pattern": "Worldwide Distribution.",
      "openfda": {
        "k_number": [
          "K881006",
          "K133157",
          "K931968",
          "K071725",
          "K843709",
          "K874839",
          "K955380",
          "K980732",
          "K862953",
          "K072131",
          "K910421",
          "K843538",
          "K103168",
          "K852124",
          "K900459",
          "K234065",
          "K001388",
          "K202154",
          "K903729",
          "K062468",
          "K163657",
          "K133658",
          "K973472",
          "K811391",
          "K915255",
          "K861277",
          "K871221",
          "K202557",
          "K110957",
          "K821159",
          "K182110",
          "K972962",
          "K915265",
          "K181923",
          "K831225",
          "K955379",
          "K871686",
          "K941922",
          "K823359",
          "K123039",
          "K091908",
          "K862069",
          "K854357",
          "K012743",
          "K173591",
          "K900682",
          "K090147"
        ],
        "registration_number": [
          "9680841",
          "2011171",
          "3019807891",
          "2029275",
          "3000126629",
          "3011560054",
          "3016618143",
          "9617601",
          "3006073153",
          "1218950",
          "1828100",
          "1118880",
          "1928237",
          "2184009",
          "1319639",
          "3002807090",
          "2245590",
          "3002807561",
          "1124841",
          "9611109",
          "3044156918"
        ],
        "fei_number": [
          "1000116158",
          "1000138054",
          "2011171",
          "3019807891",
          "3000204839",
          "3000126629",
          "1000306431",
          "3011560054",
          "3016618143",
          "3006073153",
          "3002534070",
          "3005426550",
          "1218950",
          "1828100",
          "1118880",
          "1928237",
          "3002808267",
          "3006003617",
          "2245590",
          "3002807561",
          "3044156918"
        ],
        "device_name": "Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4330",
        "device_class": "2"
      }
    }
  ]
}