{
  "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-0009  0K0S-0011- 0015  0K0S-0018  0K0S-0019  0K0S-0021- 0028  0K0S-0030- 0032  0K0S-0034- 0036  0K0S-0038- 0040  0K0S-0042  0K0S-0044- 077  0K0S-0080- 278  0K0S-0280- 285  0K0S-0287- 478  0K0S-0480- 552  0K0S-0554- 677  0K0S-0679- 884  0K0S-0886- 900  0K0S-0902- 916  0K0S-0918  0K0S-0920  0K0S-0921  0K0S-0923- 926  0K0S-0928- 934  0K0S-0936- 942  0K0S-0944- 958  0K0S-0961  0K0S-0962  0K0S-0964- 991  0K0S-0993- 0999  1K0S-1001- 4999  2K0S-5000- 9999  2K0S-A000- A999  2K0S-B000- B999  3K0S-C000- C999  3K0S-D000- D999  3K0S-E000- E999  3K0S-F000- F999  3K0S-G000- G999   3KOS-H000- H999  4H0S-J275  4K0S-J000- J999  4K0S-K000- K999  4K0S-L000- L999  4K0S-M000- M999  4K0S-N000- N999  4K0S-P000- P999  4K0S-Q000- Q999  4K0S-R000- R999  4K0S-S000- S999  4K0S-T615  4KK0S-Q907  50S-W536  5K0S-000A- 999D  5K0S-T000- T999  5K0S-U000- U999  5K0S-V000- V999  5K0S-W000- W999  5K0S-X000- X999  5K0S-Y011- Y999  5K0S-Z000- Z999  5K0-Y176  6K0S-000E- 999E  6K0S-000F- 999E  6K0S-000G- 999E  6K0S-000H- 999H  6K0S-000J- 999J  6K0S-000K- 999K  6K0S-000L- 999L  6K0S-000M- 999M  6K0S-000N- 999N  6K0S-000P- 999P  6K0S-000Q- 999Q  6K0S-000R- 999R  6K0S-000S- 999S  6K0S-000T- 159T  7K0S100001- 115591  7KOS103444  7KOS103556  7KOS104151  7KOS104219  7KOS104293  7KOS104318  8K0S115592- 121299  8K0S121301- 126597  8K0S1269573  8K0S127201- 130767  8K0S130769  8K0S130770- 131327  8K0S131329  8K0S131331  8K0S131333- 1365  8K0S131406- 1411  8K0S131417-1419  8K0S131426  8K0S131448",
      "center_classification_date": "20150429",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.",
      "state": "MA",
      "product_description": "2008 Series Hemodialysis Machines: 2008K with the following product code and description:  190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus;  190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O 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-1551-2015",
      "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"
    }
  ]
}