{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Nixa",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80317",
      "recalling_firm": "SPS Sterilization, Inc",
      "address_1": "1110 N Gerald St",
      "address_2": "N/A",
      "postal_code": "65714-7445",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution to AZ, CA, FL, OH, PA, TX, VA, WV",
      "recall_number": "Z-3030-2018",
      "product_description": "Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16\"), resterilized.",
      "product_quantity": "5 units total",
      "reason_for_recall": "The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.",
      "recall_initiation_date": "20180307",
      "center_classification_date": "20180913",
      "termination_date": "20181127",
      "report_date": "20180919",
      "code_info": "Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16"
    }
  ]
}