{
  "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": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87998",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Distribution to: TX only",
      "recall_number": "Z-2089-2021",
      "product_description": "The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay\"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay\"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay\"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.",
      "product_quantity": "5 cases",
      "reason_for_recall": "Exposed to freezing temperatures due to refrigerated truck malfunctions",
      "recall_initiation_date": "20210428",
      "center_classification_date": "20210716",
      "termination_date": "20220808",
      "report_date": "20210728",
      "code_info": "Lot Number:   20SR08069   UDI: (01)00840861100811  20PR08237   UDI: (01)00840861100811",
      "more_code_info": ""
    }
  ]
}