{
  "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-2816-2018",
      "product_description": "6\" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.",
      "product_quantity": "300 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 AM6130.      a. Lot Number 3414534, UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534,  Expiration Date 02/01/2022;    b. Lot Number 3442461, UDI Number (01) 1 0887709 08771 9 (17) 220501 (30) 50 (10) 3442461, Expiration Date 05/01/2022;    b. Lot Number 3509517, UDI Number (01) 1 0887709 08771 9 (17) 220801 (30) 50 (10) 3509517, Expiration Date 08/01/2022",
      "more_code_info": ""
    }
  ]
}