{
  "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": "Ejido Maneadero",
      "state": "",
      "country": "Mexico",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80460",
      "recalling_firm": "ICU Medical de Mexico, S.A. de C.V.",
      "address_1": "Avenida Cuarzo 250",
      "address_2": "Ensenada",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution to AZ, MA, NC, OH, TX, VA, WA.      Worldwide distribution to Belgium, France, Germany.",
      "recall_number": "Z-2797-2018",
      "product_description": "20 cm (8\") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.",
      "product_quantity": "81 pouches",
      "reason_for_recall": "ICU Medical is expanding the scope of their  previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.",
      "recall_initiation_date": "20180301",
      "center_classification_date": "20180816",
      "termination_date": "20240126",
      "report_date": "20180822",
      "code_info": "Item Number 011-AM3002.      a. Lot Number 3326545, UDI Number (01) 1 0640619 09275 4 (17) 210901 (30) 50 (10) 3326545, Expiration Date 09/01/2021;    b. Lot Number 3459161, UDI Number (01) 1 0840619 09275 4 (17) 220501 (30) 50 (10) 3459161, Expiration Date 05/01/2022",
      "more_code_info": ""
    }
  ]
}