{
  "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": "73836",
      "product_res_number": "Z-0439-2009",
      "event_date_initiated": "2008-09-29",
      "event_date_posted": "2009-01-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-07-29",
      "res_event_number": "49580",
      "product_code": "KPO",
      "k_numbers": [
        "K022521"
      ],
      "product_description": "SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.  This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.",
      "code_info": "Lot #10442, 10461 and 10462.",
      "firm_fei_number": "3003463852",
      "recalling_firm": "Rockwell Medical Technologies, Inc",
      "address_1": "4051 Freeport Pkwy Ste 100 4051 Freeport Pkwy",
      "address_2": "Ste 100",
      "city": "Grapevine",
      "state": "TX",
      "postal_code": "76099",
      "additional_info_contact": "Charlotte Tracy\n800-449-3353",
      "reason_for_recall": "Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.",
      "root_cause_description": "Environmental control",
      "action": "Recall notification was faxed and/or e-mailed to consignees on 09/29/08 and then sent via mail on 09/30/08.  A follow-up response form was faxed to consignees starting 10/01/08.\n\nConsignees asked to return product for a credit.  For additional information, contact Rockwell Medical Technologies, Inc., Customer Service at 1-800-449-3353.",
      "product_quantity": "2,281 cases (4 units per case)",
      "distribution_pattern": "Nationwide.  Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.",
      "openfda": {
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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": [
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