{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "105526",
      "product_res_number": "Z-0604-2012",
      "event_date_initiated": "2011-12-07",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-08-30",
      "res_event_number": "60479",
      "product_code": "DRY",
      "product_description": "CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.",
      "code_info": "Catalog number :101; Serial Numbers: 1070, 1071, 1076, 1077, 1080, 1083, 1104, 1107, 1108, 1115-1117, 1124, 1127, 1128, 1132-1134, 1136, 1137, 1139-1144, 1148, 1151, 1152, 1154-1156, 1160-1162, 1166, 1168-1173, 1182,1185,1186,1190,1192, 1193, 1195, 1239-1241, 1243-1245, 1247, 1249-1257,1261, 1264-1266, 1268-1277,1279, 1280, 1282-1289, 1297,1299-1301, 1306-1311, 1313-1318, 1321-1324, 1337-1339, 1350-1355, 1357-1363, 1365-1377, 1382, 1386, 1406-1409, 1411, 1413,1414, 1417-1422, 1428-1436, 1440, 1441, 1443-1447, 1450-1453, 1455-1458, 1460, 1463, 1469-1482, 1484, 1486, 1488, 1492,1503-1511 ,1513, 1515-1520, 1532-1534, 1537, 1540, 1542, 1543, 1547, 1548, 1550, 1551, 1555, 1560-1563, 1568-1574, 1578, 1579, 1585-1596, 1598, 1614, 1615, 1617-1622, 1625-1629, 1632-1647, 1653, 1655, 1660, 1666, 1667, 1669-1676, 1679, 1681, 1682, 1690, 1693, 1694, 1696, 1699, 1705-1709, 1713, 1714, 1726, 1729-1734,1738, 1745-1750,1752-1756,1760, 1764-1768, 1771, 1773-1777,1785,1787,1788,1790-1794,1797-1799,1801-1808,1816,1818-1821, 1823, 1826, and 1839.",
      "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 is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device.",
      "root_cause_description": "No Marketing Application",
      "action": "12/7/11 & 12/8/11 All consignees received a \"Transition and Notification Guide\" dated 12/6/11 and a \"URGENT MEDICAL DEVICE REMOVAL\" letter dated 12/4/11, which will inform them of the removal of the CD l 101 and provide the user with various options. Terumo will remove CD l 101 units from the US market over the next 18 months.",
      "product_quantity": "366",
      "distribution_pattern": "Nationwide Distribution - Including the states of: NV, MO, SC, WA, MI, FL, GA, NY, CT, IL, VA, NY, TN, IN, HI, TX, AL, OH, MD, AZ, CA, KS, MD, PA, and NM.",
      "openfda": {
        "k_number": [
          "K173591",
          "K181923",
          "K182110",
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          "K202557",
          "K862069",
          "K133157",
          "K821159",
          "K915255",
          "K980732",
          "K910421",
          "K202154",
          "K103168",
          "K072131"
        ],
        "registration_number": [
          "9617601",
          "1118880",
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          "3019807891",
          "1218950",
          "2184009",
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        "fei_number": [
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        ],
        "device_name": "Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4330",
        "device_class": "2"
      }
    }
  ]
}