{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
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  "results": [
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      "cfres_id": "221802",
      "product_res_number": "Z-3091-2026",
      "event_date_initiated": "2026-07-14",
      "event_date_posted": "2026-09-03",
      "recall_status": "Open, Classified",
      "res_event_number": "99543",
      "product_code": "KPO",
      "k_numbers": [
        "K192209"
      ],
      "product_description": "GRANUFLO Dry Acid Concentrate:  Product Numbers:  0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis",
      "code_info": "1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers:  26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; \n2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers:  26AXGF014, 26AXGF018.",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Renal Therapies Group, LLC",
      "address_1": "920 Winter St Bld 920",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "Fresenius Medical Care Customer Service\n800-323-5188",
      "reason_for_recall": "Complaints of blue-green discoloration in product",
      "root_cause_description": "Material/Component Contamination",
      "action": "Fresenius Medical Care issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/15/2026 via USPS first class mail.  The notice explained the issue, potential risk and requested the following action:  \n\"1. Identify if you have any affected product lots on hand.  \n2. IMMEDIATELY segregate and discontinue use of affected lots.  \n3. Contact FMCRTG (1-833-203-5448) between 8:00 AM   8:00 PM Eastern daily, for return of affected lots and replacement of your stock.  \n4. Complete and return the attached REPLY FORM.\"  \nFor any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.",
      "product_quantity": "27,216 cs; 2,316 ea",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Mexico.",
      "openfda": {
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
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