{
  "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": "105576",
      "product_res_number": "Z-0674-2012",
      "event_date_initiated": "2011-12-06",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-03-01",
      "res_event_number": "60151",
      "product_code": "DRY",
      "k_numbers": [
        "K972962"
      ],
      "product_description": "CDI Blood Parameter Monitoring System 500\n\nProduct Usage:  The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.",
      "code_info": "Catalog Number: 500AHCT CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe.",
      "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": "In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented:\nTerumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all",
      "root_cause_description": "Component change control",
      "action": "Terumo sent an \"URGENT MEDICAL DEVICE CORRECTION\" letter dated December 6, 2011. The letter identified the affected products, the problem, and the actions to be taken by customer/user.  The letter states that Terumo CVS will update all affected CDl Monitors and no additional actions are necessary for those units previously returned that received the correction as part of the  service process.  For questions or concerns contact Terumo CVS Customer Service 1-800-521-2818.",
      "product_quantity": "451 units total",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide in the states of: AR, AZ, CA, FL, KS, IL, IN, LA, MA, MO, MI, MS, NJ, NV, NC, OH, PA, TN, TX, VA, WA, WI, WV including Puerto Rico and the countries of:  AE, Australia, BR, Belgium,  Brazil, Canada, China, Dominican Republic, EC, Germany,  Guatemala, Japan, Korea, Mexico, SA, Taiwan and UY.",
      "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"
      }
    }
  ]
}