{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "115213",
      "product_res_number": "Z-0683-2013",
      "event_date_initiated": "2012-11-26",
      "event_date_posted": "2013-01-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-06-21",
      "res_event_number": "63768",
      "product_code": "KPO",
      "k_numbers": [
        "K030497"
      ],
      "product_description": "Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 3.0K  2,0 Ca 1.0Mg .16.5GAL\nCatalog Number: OFD3201-3B\n\nProduct Usage:\nGranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.",
      "code_info": "Lot Number:12PXGF017",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "800-662-1237",
      "reason_for_recall": "GranuFlo Dry Acid Concentrate may show discoloration",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Fresenius Medical Care North America notified consignees by telephone on November 26, 2012 and follow-up  letter on November 30, 2012 of the product recall.  On January 10, 2013, the firm expanded there recall to an additional 32 lots (34 lots total). Customers were instructed to examine their inventory immediately, discontinue use, place all units in quarantine and return to Fresenius Medical Care North America.  Customers were advised to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. For questions contact the GranuFio Recall Line at 1-888-803-0509",
      "product_quantity": "670 units",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
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          "K954527",
          "K001059",
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          "K922990",
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          "K012328",
          "K022521",
          "K041683",
          "K901473",
          "K911459",
          "K910270"
        ],
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "1651896",
          "3005578748",
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