{
  "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-2800-2018",
      "product_description": "DISTALE - 203 cm (80\") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.",
      "product_quantity": "122 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-AM3006.  Lot Number 3508532, UDI Number (01) 1 0840619 09320 1 (17) 220601 (30) 20 (10) 3508532 , Expiration Date 08/01/2022",
      "more_code_info": ""
    }
  ]
}