{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130173",
      "product_res_number": "Z-0018-2015",
      "event_date_initiated": "2014-09-17",
      "event_date_posted": "2014-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-10-27",
      "res_event_number": "69276",
      "product_code": "LDY",
      "product_description": "Cardinal Health Prefilled Buffered 10% Formalin.\n\nProduct Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.",
      "code_info": "Product Code: C4320-450B Lot Number: 300403",
      "firm_fei_number": "1831638",
      "recalling_firm": "Richard-Allan Scientific Company",
      "address_1": "4481 Campus Dr",
      "city": "Kalamazoo",
      "state": "MI",
      "postal_code": "49008-2590",
      "additional_info_contact": "Sarah Rickert\n616-385-4466",
      "reason_for_recall": "The affected lots could have NBF concentrations that are lower or higher than the desired specifications.",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "The firm issued an \"URGENT MEDICAL DEVICE RECALL\" letter to all affected customers.  The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form.  For questions, contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher.com.",
      "product_quantity": "235 cases",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.",
      "openfda": {
        "registration_number": [
          "3008174888",
          "3010194621",
          "3010420046",
          "1640981",
          "3009963993",
          "3010461097",
          "2247035",
          "3007496191",
          "1419341",
          "3002805583",
          "3003703247",
          "1063851",
          "3004074729",
          "1831638",
          "2013736",
          "3003335080",
          "1831312",
          "3010692993",
          "3015505238",
          "3022312148",
          "1930126",
          "2244900"
        ],
        "fei_number": [
          "3008174888",
          "3010194621",
          "3010420046",
          "1640981",
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          "3010461097",
          "3007496191",
          "1000122268",
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          "1831638",
          "2013736",
          "3003335080",
          "1831312",
          "3010692993",
          "3015505238",
          "3022312148",
          "1000442352",
          "1930126",
          "2244900"
        ],
        "device_name": "Fixative, Formalin-Containing",
        "medical_specialty_description": "Pathology",
        "regulation_number": "864.4010",
        "device_class": "1",
        "k_number": [
          "K880549"
        ]
      }
    }
  ]
}