{
  "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-2801-2018",
      "product_description": "216 cm (85\") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.",
      "product_quantity": "50 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-AM3010.  Lot Number 3424312, UDI Number (01) 1 0840619 09487 1 (17) 220301 (30) 50 (10) 3424312, Expiration Date 03/01/2022",
      "more_code_info": ""
    }
  ]
}