{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Elkton",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76386",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "125 Blue Ball Rd",
      "address_2": "N/A",
      "postal_code": "21921-5315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall",
      "recall_number": "Z-1235-2017",
      "product_description": "The Sarns Centrifugal Pump is a single use device  sterilized by ethylene oxide gas.  The device  is sold single sterile in cartons  of 8 units, or may be provided in bulk, non-sterile to another Terumo location  for inclusion in Cardiovascular Procedure Kits.   Cardiovascular Procedure kits are packaged individually.",
      "product_quantity": "579 units have entered into the distribution chain",
      "reason_for_recall": "Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures.    In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks.    Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.",
      "recall_initiation_date": "20150527",
      "center_classification_date": "20170222",
      "termination_date": "20170223",
      "report_date": "20170301",
      "code_info": "TAOS, TC03"
    }
  ]
}