{
  "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": "2026-04-15",
    "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": "79478",
      "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": "E-Mail",
      "distribution_pattern": "US Distribution to the states of:  AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.",
      "recall_number": "Z-1278-2018",
      "product_description": "2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number)    ndicated for acute and chronic dialysis therapy.",
      "product_quantity": "127",
      "reason_for_recall": "When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.",
      "recall_initiation_date": "20171214",
      "center_classification_date": "20180330",
      "termination_date": "20210922",
      "report_date": "20180411",
      "code_info": "Serial Numbers: 0K0S151801     UDI 00840861100866 190630,(+Serial Number)  UDI 00840861100859  PLS 190610, (+Serial Number    1K0S169898  1K0S169954  1K0S170154  1K0S170234  1K0S171275  1K0S171286  1K0S171421  1K0S171436  2K0S176243  2K0S176244  2K0S176257  2K0S176264  2K0S176271  2K0S176273  2K0S176278  2K0S176280  2K0S176281  2K0S176283  2K0S176286  2K0S176443  2K0S176472  2K0S176633  4K0S188834  4K0S188841  4K0S188843  4K0S188987  4K0S189246  4K0S189293  4K0S189300  4K0S189353  4K0S189488  4K0S189797  4K0S189915  4K0S189939  4K0S190064  4K0S190067  4K0S190091  4K0S190111  4K0S190115  4K0S190119  4K0S190121  4K0S190126  4K0S190140  4K0S190141  4K0S190145  4K0S190146  4K0S190166  4K0S190173  4K0S190175  4K0S190183  4K0S190203  4K0S190212  4K0S190222  4K0S190226  4K0S191575  4K0S191910  5K0S193681  5K0S193682  5K0S193688  5K0S193689  5K0S193690  5K0S193696  5K0S193699  5K0S193701  5K0S193702  5K0S193707  5K0S193710  5K0S193711  5K0S193712  5K0S193713  5K0S193721  5K0S193732  5K0S193733  5K0S193734  5K0S193735  5K0S193736  5K0S193737  5K0S193740  5K0S193741  5K0S193747  5K0S193750  5K0S193753  5K0S193756  5K0S193757  5K0S193758  5K0S193761  5K0S193765  5K0S193769  5K0S193774  5K0S193776  5K0S193777  5K0S193778  5K0S193781  5K0S193783  5K0S193788  5K0S193789  5K0S193790  5K0S193794  5K0S193798  5K0S193799  5K0S193801  5K0S193808  5K0S193812  5K0S193820  5K0S193822  5K0S193823  5K0S193824  5K0S193830  5K0S193834  5K0S193835  5K0S193839  5K0S193842  5K0S193843  5K0S193851  5K0S193853  5K0S193854  5K0S193861  5K0S193864  5K0S193865  5K0S193866  5K0S193867  5K0S193872  5K0S193875  5K0S193877  5K0S193879  5K0S193883  5K0S193887  5K0S193889  5K0S193891  5K0S193892  5K0S193895  5K0S193898  5K0S193900  5K0S193901  5K0S193902  5K0S193903  5K0S193904  5K0S193905  5K0S193909  5K0S193910  5K0S193912  5K0S193914  5K0S193916  5K0S193917  5K0S193918  5K0S193919  5K0S193920  5K0S193921  5K0S193922  5K0S193924  5K0S193925  5K0S193927  5K0S193928  5K0S193929  5K0S193930  5K0S193932  5K0S193935  5K0S193937  5K0S193940  5K0S193944  5K0S193946  5K0S193948  5K0S193957  5K0S193963  5K0S193965  5K0S193966  5K0S193975  5K0S193976  5K0S193981  5K0S193983  5K0S193986  5K0S193987  5K0S193988  5K0S193991  5K0S193992  5K0S193995  5K0S193998  5K0S193999  5K0S194004  5K0S194007  5K0S194008  5K0S194010  5K0S194016  5K0S194021  5K0S194028  5K0S194032  5K0S194033  5K0S194035  5K0S194041  5K0S194045  5K0S194046  5K0S194051  5K0S194059  5K0S194065  5K0S194067  5K0S194068  5K0S194071  5K0S194072  5K0S194074  5K0S194075  5K0S194077  5K0S194079  5K0S194080  5K0S194098  5K0S194099  5K0S194101  5K0S194102  5K0S194104  5K0S194106  5K0S194107  5K0S194109  5K0S194111  5K0S194112  5K0S194113  5K0S194118  5K0S194122  5K0S194125  5K0S194126  5K0S194127  5K0S194130  5K0S194132  5K0S194133  5K0S194134  5K0S194136  5K0S194139  5K0S194141  7K0S-103983  8K0S126369ZZNOTUSE  8K0S131332  8K0S132008  8K0S132012  9K0S133294  9K0S139189  9K0S141552"
    }
  ]
}