{
  "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": [
    {
      "country": "United States",
      "city": "Waltham",
      "address_1": "920 Winter St",
      "reason_for_recall": "The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.",
      "address_2": "",
      "product_quantity": "133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)",
      "code_info": "Serial Numbers:  0K0S-0678  0K0S-0885  0K0S-0901  0K0S-0917  0K0S-0922  0K0S-0927  0K0S-0935  0K0S-0943  0K0S-0959  0K0S-0960  0K0S-0963  0K0S-0992  0K0S149209-149999  0K0S150000- 152000  0K0S152001- 154000  0K0S154001- 160000  0K0S160001- 162000  0K0S162001- 165353  0S154030  1K0S-1000  1K0S-1022  1K0S-1027  1K0S-1029  1K0S-1035  1K0S-1037  1K0S-1044- 1046  1K0S-1065  1K0S-1067  1K0S-1070  1K0S-1094  1K0S-1095  1K0S-1102  1K0S-1103  1K0S-1121  1K0S165354- 174103  2K0S174104  2K0S174105- 174111  2K0S174150- 182134  2K0S-5783  2K0S-5802  2K0S-6015  2K0S-6046  2K0S-6065  2K0S-6067  2K0S-6109  2K0S-6232  2K0S-6266  2K0S-9573  3K0S182135- 188639  4K0S188640- 192508  4K0S192542  4K0S192545  4K0S192550- 192553  4K0S192555  4K0S192566- 192569  4K0S192571  4K0S192572  4K0S192575- 192577  4K0S192579  4K0S192581  4K0S192584- 192586  4K0S192588  4K0S192593  4K0S192602  4K0S192603  4K0S192605  4K0S192675  4K0S192738- 192740  4K0S-N592  4K0S-Q302  4K0S-Q350  4K0S-Q362  4K0S-Q425  4K0S-Q467  4K0S-Q470  4K0S-Q502  5K0S-132B  5K0S-856B  5K0S-T230  5K0S-V420  5K0S-X901  5K0S-Y378  6K0S-029N  6K0S-151Q  6K0S-180Q  6K0S-205M  6K0S-239M  6K0S-255N  6K0S-315N  6K0S-331Q  6K0S-821G  6K0S-903R  6K0S-942S  7K0S103279  7K0S103983  7K0S104826  7K0S112150  7K0S112155  7K0S115550  8K0S118640  8K0S121287  8K0S122793  8K0S126296- 126305  8K0S126314- 126323  8K0S126573  8K0S128448  8K0S128506  8K0S129030- 129033  8K0S129211- 129321  8K0S129335  8K0S129337- 129339  8K0S129369  8K0S129431- 129435  8K0S129440  8K0S129447- 129490  8K0S129503- 129516  8K0S129893  8K0S130289  8K0S130296  8K0S130300  8K0S130304  8K0S130324  8K0S130345  8K0S130347  8K0S130546  8K0S130548  8K0S130552  8K0S130556  8K0S130559  8K0S130565  8K0S130567  8K0S130571  8K0S130574  8K0S130726  8K0S130751  8K0S130768  8K0S130771- 130773  8K0S130819  8K0S130951  8K0S131043  8K0S131046  8K0S131120  8K0S131133  8K0S131328  8K0S131330  8K0S131449- 132162  9K0S132163- 135000  9K0S135001- 149208  9KOS137160  OKOS149422",
      "center_classification_date": "20150429",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.",
      "state": "MA",
      "product_description": "2008 Series Hemodialysis Machines: 2008K2 with the following product code and description:  190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH HEPARIN PUMP    The Fresenius 2008K is indicated for acute and chronic dialysis therapy.",
      "report_date": "20150506",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "recall_number": "Z-1552-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70574",
      "termination_date": "20210518",
      "more_code_info": "",
      "recall_initiation_date": "20150220",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}