{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "WAYNE",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82533",
      "recalling_firm": "GETINGE US SALES LLC",
      "address_1": "45 BARBOUR POND DR",
      "address_2": "N/A",
      "postal_code": "07470",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.",
      "recall_number": "Z-1221-2019",
      "product_description": "Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg  Product Code/REF Number: 6685775    Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.",
      "product_quantity": "17 boxes (5 catheters per box)",
      "reason_for_recall": "Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes",
      "recall_initiation_date": "20190320",
      "center_classification_date": "20190425",
      "termination_date": "20200408",
      "report_date": "20190501",
      "code_info": "Lot Number: 92265355  UDI Code: 6685775: 07325710002100"
    }
  ]
}