{
  "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": "94913",
      "product_res_number": "Z-0427-2011",
      "event_date_initiated": "2010-09-24",
      "event_date_posted": "2010-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-02",
      "res_event_number": "56913",
      "product_code": "KDN",
      "k_numbers": [
        "K073693"
      ],
      "product_description": "Belzer UW Cold Storage Solution, 1000 mL.  Sterile and non-pyrogenic.  Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by:  Preservation Solutions, Inc., Elkhorn, WI  53121.  Manufactured for:  BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC  29201.",
      "code_info": "Batch # Bt017170, Lot# BC071710",
      "firm_fei_number": "1000221028",
      "recalling_firm": "Preservation Solutions Inc",
      "address_1": "980 Proctor Dr.",
      "address_2": "P.O. Box 937",
      "city": "Elkhorn",
      "state": "WI",
      "postal_code": "53121-0937",
      "additional_info_contact": "Bobbi Rader\n262-723-6715",
      "reason_for_recall": "Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. \nCustomers with questions about this recall can contact Bridge to Life at 803 673-4548..",
      "product_quantity": "55 units",
      "distribution_pattern": "Nationwide Distribution - in US to the states of CA, MO, and PA.",
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        "device_name": "System, Perfusion, Kidney",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5880",
        "device_class": "2",
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