{
  "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": "80875",
      "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 in the states of :  CA, CT, MI, NC, and NY.",
      "recall_number": "Z-3195-2018",
      "product_description": "2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138    Product Usage:  Indicated for acute and chronic dialysis therapy.",
      "product_quantity": "40",
      "reason_for_recall": "In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.",
      "recall_initiation_date": "20180713",
      "center_classification_date": "20180918",
      "termination_date": "20190917",
      "report_date": "20180926",
      "code_info": "6T0S160600, 6T0S160624, 6T0S160672, 6T0S160695, 6T0S160732, 6T0S160740, 6T0S160773, 6T0S160781, 6T0S160785, 6T0S160841, 4T0S135962  4T0S135963  4T0S135970  4T0S135972  4T0S135980  4T0S135985  4T0S135987  4T0S136000  4T0S136003  4T0S136070  4T0S136071  4T0S136072  4T0S136077  4T0S136078  4T0S136080  4T0S136081  4T0S136082  4T0S136084  4T0S136088  4T0S136090  4T0S136091  4T0S136106  4T0S136111  4T0S136112  4T0S136114  4T0S136115  4T0S136117  4T0S136120  4T0S136121  4T0S136123"
    }
  ]
}