{
  "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-3194-2018",
      "product_description": "2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138    Product Usage:  Indicated for acute and chronic dialysis therapy.",
      "product_quantity": "80",
      "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": "3T0S119726, 3T0S119741, 3T0S119747, 3T0S119753, 3T0S119762, 3T0S119775, 3T0S119792, 3T0S119801, 3T0S119806, 3T0S119807, 3T0S119818, 3T0S119823, 3T0S119824, 3T0S119848, 3T0S119863, 3T0S119910, 3T0S119948, 3T0S119965, 3T0S119984, 3T0S120097, 3T0S120134, 3T0S120200, 1T0S104090  1T0S104108  1T0S104116  1T0S104166  1T0S104169  1T0S104188  1T0S104189  1T0S104191  1T0S104216  1T0S104224  1T0S104240  1T0S104249  1T0S104278  1T0S104293  1T0S104303  1T0S104310  1T0S104324  1T0S104325  1T0S104334  1T0S104357  3T0S121680  4T0S126717  4T0S126764  4T0S126782  0T0S101039  0T0S101123  0T0S101144  0T0S101182  0T0S101197  0T0S101220  0T0S101231  0T0S101232  0T0S101236  0T0S101238  0T0S101240  0T0S101252  0T0S101298  0T0S101324  0T0S101329  0T0S101341  0T0S101344  0T0S101345  0T0S101352  3T0S118641  3T0S118661  3T0S118662  3T0S118670  3T0S118675  3T0S118682  3T0S118695  3T0S118698  3T0S118699  3T0S118702  3T0S118703  3T0S118721  3T0S118723  3T0S118726  3T0S118734  3T0S118754"
    }
  ]
}