{
  "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": "2,950 pouches",
      "code_info": "Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848; lot number 3511823, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3511823; lot number 3516092, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3516092; and lot number 3545075, UDI (01) 0 0887709 01806 8 (17) 221001 (30) 01 (10) 3545075.",
      "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\" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case,  Item B9900-629, Sterile, Rx.  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-1345-2018",
      "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"
    }
  ]
}