{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48080",
      "product_res_number": "Z-0236-2007",
      "event_date_initiated": "2006-09-14",
      "event_date_posted": "2006-12-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-06-19",
      "res_event_number": "36150",
      "product_code": "DTW",
      "k_numbers": [
        "K915183"
      ],
      "product_description": "Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.",
      "code_info": "Serial numbers 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1143-1194 and 1196 through 1245.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "6200 Jackson Rd",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "800-521-2818",
      "reason_for_recall": "The hand crank handle may separate and detach from the unit during use.",
      "root_cause_description": "Other",
      "action": "Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles.  The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.",
      "product_quantity": "124",
      "distribution_pattern": "Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",
      "openfda": {
        "k_number": [
          "K910599",
          "K781145",
          "K900815",
          "K992857",
          "K822821",
          "K831879",
          "K900910",
          "K860076",
          "K924354",
          "K150530",
          "K843802",
          "K955152",
          "K852407",
          "K041558",
          "K873206",
          "K823712",
          "K915337"
        ],
        "registration_number": [
          "1828100",
          "3015431638",
          "9617604",
          "2025816",
          "2184009",
          "2032112"
        ],
        "fei_number": [
          "1828100",
          "3003076831",
          "3015431638",
          "1000116158",
          "3002558692",
          "2025816"
        ],
        "device_name": "Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4340",
        "device_class": "2"
      }
    }
  ]
}