{
  "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-0159-2015",
      "product_description": "Terumo Custom Cardiovascular and Perfusion Procedure Kits  Catalog Codes: Kits with a 5-digit code beginning with the digit  6:   Catalog Number: 6XXXX ;  Catalog Codes: Kits with a 5-digit code beginning with the digit  7: Catalog Number: 7XXXX     Product usage:  The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.",
      "product_quantity": "Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 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: 6XXXX  Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22.   Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0.    Catalog Number: 7XXXX  Lot Numbers:  ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13.  Manufacturing dates September 7, 2010 through December 13,2010."
    }
  ]
}