{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Rd",
      "reason_for_recall": "H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip Test Failure which disables the H/Sat module.",
      "address_2": "",
      "product_quantity": "128 in total",
      "code_info": "H011684                         H011685                         H011686                         H011687                         H011688                         H011689                         H011691                         H011692                         H011693                         H011694                         H011695                         H011696                         H011697                         H011699                         H011700                         H011701                         H011702                         H011704                         H011705                         H011706                         H011707                         H011708                         H011709                         H011710                         H011711                         H011712                         H011713                         H011714                         H011715                         H011717                         H011718                         H011719                         H011721                         H011722                         H011723                         H011725                         H011726                         H011727                         H011730                         H011731                         H011732                         H011733                         H011735                         H011736                         H011737                         H011738                         H011742                         H011744                         H011745                         H011747                         H011749                         H011750                         H011751                         H011752                         H011753                         H011754                         H011755                         H011756                         H011757                         H011758                         H011759                         H011760                         H011761                         H011762                         H011766                         H011772                         H011778                         H011779                         H011780                         H011781                         H011783                         H011784                         H011785                         H011786                         H011788                         H011789                         H011790                         H011791                         H011792                         H011793                         H011794                         H011795                         H011796                         H011797                         H011798                         H011799                         H011800                         H011801                         H011803                         H011804                         H011805                         H011806                         H011807                         H011808                         H011809                         H011810                         H011811                         H011812                         H011813                         H011814                         H011815                         H011817                         H011819                         H011821                         H024598                         H024599                         H024600                         H024601                         H024602                         H024603                         H024604                         H024605                         H024606                         H024607                         H024608                         H024611                         H024612                         H024613                         H024614                         H024615                         H024616                         H024617                         H024618                         H024620                         H024621                         H024624                         H024625                         H024626                         H024627                         H024628                         H024629                         H024631                         H024632                         H024633                         H024635                         H024636                         H024637                         H024638                         H024639                         H024641                         H024642                         H024643                         H024645                         H024647                         H024649                         H024652                         H024654                         H024655                         H024657                         H024659                         H024674",
      "center_classification_date": "20180810",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, SC, TN, TX, WA, and WV. Foreign distribution to Middle East, Latin America, Europe, Japan, Canada, and Mexico.",
      "state": "MI",
      "product_description": "CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883    Product Usage:  The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.",
      "report_date": "20180822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-2750-2018",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "80530",
      "termination_date": "20200417",
      "more_code_info": "",
      "recall_initiation_date": "20180626",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}