{
  "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": "149395",
      "product_res_number": "Z-0001-2017",
      "event_date_initiated": "2015-12-11",
      "event_date_created": "2016-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-10-26",
      "res_event_number": "75118",
      "product_code": "DRY",
      "k_numbers": [
        "K915265"
      ],
      "product_description": "CDI H/S Cuvette\n\nThe intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.",
      "code_info": "6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various",
      "firm_fei_number": "3000204839",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "125 Blue Ball Rd",
      "city": "Elkton",
      "state": "MD",
      "postal_code": "21921-5315",
      "additional_info_contact": "410-392-7277",
      "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.",
      "root_cause_description": "Other",
      "action": "Terumo (Planned Action) plans to execute the following steps as part of the correction activity:\n\nNotify all customers of the potential that a cuvette may disengage from the circuit (probe) leading to a \"disconnect\" message on the monitor. This notification will be performed via a Customer Notification Letter. \n\nFor further questions, please call (410) 392-7277.",
      "product_quantity": "140,000  units",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution.",
      "openfda": {
        "k_number": [
          "K973472",
          "K874839",
          "K831225",
          "K062468",
          "K012743",
          "K202154",
          "K234065",
          "K980732",
          "K903729",
          "K862069",
          "K955379",
          "K821159",
          "K811391",
          "K110957",
          "K072131",
          "K202557",
          "K173591",
          "K871221",
          "K843709",
          "K915265",
          "K941922",
          "K181923",
          "K163657",
          "K915255",
          "K900459",
          "K931968",
          "K843538",
          "K001388",
          "K182110",
          "K861277",
          "K871686",
          "K090147",
          "K071725",
          "K133658",
          "K854357",
          "K910421",
          "K123039",
          "K823359",
          "K133157",
          "K862953",
          "K955380",
          "K091908",
          "K852124",
          "K972962",
          "K103168",
          "K881006",
          "K900682"
        ],
        "registration_number": [
          "3044156918",
          "3019807891",
          "3011560054",
          "1319639",
          "3002807090",
          "1124841",
          "3016618143",
          "1218950",
          "9611109",
          "9680841",
          "1928237",
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          "3006073153",
          "2011171",
          "3002807561",
          "2029275",
          "2184009",
          "3000126629",
          "9617601"
        ],
        "fei_number": [
          "3044156918",
          "3019807891",
          "3011560054",
          "3002534070",
          "3016618143",
          "1218950",
          "3000204839",
          "1000116158",
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          "1828100",
          "1000138054",
          "1118880",
          "2245590",
          "3002808267",
          "3006073153",
          "2011171",
          "3002807561",
          "1000306431",
          "3005426550",
          "3000126629"
        ],
        "device_name": "Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4330",
        "device_class": "2"
      }
    }
  ]
}