{
  "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-2813-2018",
      "product_description": "10\" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer",
      "product_quantity": "650 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 AM6109.      a. Lot Number 3373758, UDI Number (01) 1 0887709 07764 2, Expiration Date 12/01/2021;    b. Lot Number 3391364, UDI Number (01) 1 0887709 07764 2 (17) 220101 (30) 50 (10) 3391364, Expiration Date 01/01/2022;    c. Lot Number 3511445, UDI Number (01) 1 0887709 07764 2 (17) 220801 (30) 50 (10) 3511445, Expiration Date 08/01/2022",
      "more_code_info": ""
    }
  ]
}