{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ashland",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "58185",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "28 Howe St",
      "address_2": "N/A",
      "postal_code": "01721-1305",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and the countries of  Canada, Brazil, Hong Kong, Korea, and Thailand.",
      "recall_number": "Z-0160-2015",
      "product_description": "Terumo Custom Cardioplegia Delivery Set-  Catalog Number:165720 and Catalog Number: 6375    Product Usage:  Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.",
      "product_quantity": "Catalog: 16579 ; Catalog 6375: 3256 units",
      "reason_for_recall": "Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line",
      "recall_initiation_date": "20110301",
      "center_classification_date": "20141031",
      "termination_date": "20141106",
      "report_date": "20141112",
      "code_info": "Catalog Number:  165720  Lot Numbers:  MDI5, MD15B,  MD22, ME19, MP13.  Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0.    Catalog Number: 6375  Lot Numbers: MD15, ME19, MPI3   Manufacturing dates March 15, 2010 through December 13, 20 I 0"
    }
  ]
}