{
  "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": "2026-04-08",
    "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": "79239",
      "recalling_firm": "Fresenius Medical Care Renal Therapies Group, LLC",
      "address_1": "920 Winter St",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-0829-2018",
      "product_description": "2008T, Hemodialysis Delivery System    Product Indicated for acute and chronic dialysis therapy.",
      "product_quantity": "15 machines",
      "reason_for_recall": "While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.",
      "recall_initiation_date": "20171005",
      "center_classification_date": "20180301",
      "termination_date": "20210728",
      "report_date": "20180307",
      "code_info": "2008T machines:  190766 2008T Hemodialysis System w/Bibag  190895 2008T GEN 2 Bibag without CDX    190766 = 00840861100910 (+Serial Number)  190895 = 00840861100927 (+Serial Number)ux=&Su"
    }
  ]
}