{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020171"
        ],
        "brand_name": [
          "DELFLEX"
        ],
        "generic_name": [
          "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Medical Care Renal Therapies Group, LLC"
        ],
        "product_ndc": [
          "49230-206",
          "49230-209",
          "49230-212"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAPERITONEAL"
        ],
        "substance_name": [
          "CALCIUM CHLORIDE",
          "DEXTROSE MONOHYDRATE",
          "MAGNESIUM CHLORIDE",
          "SODIUM CHLORIDE",
          "SODIUM LACTATE"
        ],
        "spl_id": [
          "43cd31e0-97ed-1eeb-e063-6294a90a0b3d"
        ],
        "spl_set_id": [
          "c29bdfa0-4976-11e2-939b-0002a5d5c51b"
        ],
        "package_ndc": [
          "49230-206-92",
          "49230-206-94",
          "49230-206-95",
          "49230-209-92",
          "49230-209-94",
          "49230-209-95",
          "49230-212-92",
          "49230-212-94",
          "49230-212-95"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TU7HW0W0QT",
          "451W47IQ8X",
          "M4I0D6VV5M",
          "02F3473H9O",
          "LX22YL083G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94887",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 920",
      "address_2": "",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0608-2024",
      "product_description": "DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay \"safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94",
      "product_quantity": "183 cases",
      "reason_for_recall": "This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.",
      "recall_initiation_date": "20240618",
      "center_classification_date": "20240717",
      "report_date": "20240724",
      "code_info": "24AU03024, exp. date 07/31/2025",
      "more_code_info": ""
    }
  ]
}