{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80946",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "address_2": "",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.",
      "recall_number": "Z-0069-2019",
      "product_description": "ICU Medical 14\" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28     The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).",
      "product_quantity": "2361 Units",
      "reason_for_recall": "Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.",
      "recall_initiation_date": "20180820",
      "center_classification_date": "20181004",
      "report_date": "20181010",
      "code_info": "lots: 85-540-SJ, 86-189-SL, 86-911-SJ",
      "more_code_info": ""
    }
  ]
}