{
  "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": [
    {
      "country": "United States",
      "city": "San Clemente",
      "address_1": "951 Calle Amanecer",
      "reason_for_recall": "Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.",
      "address_2": "",
      "product_quantity": "",
      "code_info": "REF:  011-H3597    UDI:  (01) 1 0840619 06655 1 (17) 260101 (30) 50 (10) 5125225    Lot Number:  5125225",
      "center_classification_date": "20210513",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.",
      "state": "CA",
      "product_description": "REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: 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).",
      "report_date": "20210519",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "ICU Medical, Inc.",
      "recall_number": "Z-1583-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "87703",
      "more_code_info": "",
      "recall_initiation_date": "20210316",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}