{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "San Clemente",
      "address_1": "951 Calle Amanecer",
      "reason_for_recall": "The infusion sets were manufactured with an incorrect spin collar.",
      "address_2": "",
      "product_quantity": "250 pouches",
      "code_info": "Lot number 3483247, UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3483247; lot number 3484722, UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3484722; and lot number 3489328, UDI (01) 0 0887709 08949 5 (17) 220701 (30) 01 (10) 3489328.",
      "center_classification_date": "20180410",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to state in AZ, CA, CO,  FL, SC, and TX; and countries of: Canada and Japan.",
      "state": "CA",
      "product_description": "7\" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262.  The firm name on the label is icumedical, San Clemente, CA.     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).",
      "report_date": "20180418",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "ICU Medical, Inc.",
      "recall_number": "Z-1344-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79077",
      "termination_date": "20190917",
      "more_code_info": "",
      "recall_initiation_date": "20180205",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}