{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "150226",
      "product_res_number": "Z-0370-2017",
      "event_date_initiated": "2016-10-12",
      "event_date_posted": "2016-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-08-19",
      "res_event_number": "75414",
      "product_code": "KDL",
      "k_numbers": [
        "K060195"
      ],
      "product_description": "GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634\n\n\nProduct Usage:\nThe Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.",
      "code_info": "C416201601",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Baxter Healthcare Center for One\n800-422-9837",
      "reason_for_recall": "Potential presence of particulate matter on the blood side of the dialyzer",
      "root_cause_description": "Process control",
      "action": "Baxter sent an Urgent Product Recall letter dated October 12, 2016 to affected customers.  The letter identified the affected product, problem and actions to be taken.  Customers were instructed to:\nI. Locate and remove all affected product lots from their facility.\n2. Contact Baxter Healthcare Center for Service to arrange for return and credit.\n3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email.\n\nFor questions contact Baxter Product Surveillance at 800-437-5176.",
      "product_quantity": "22,656 units",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.",
      "openfda": {
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          "K221387",
          "K884609",
          "K944866",
          "K211842",
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          "K170150",
          "K091656",
          "K221386",
          "K900492",
          "K043461",
          "K121618"
        ],
        "device_name": "Set, Perfusion, Kidney, Disposable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5880",
        "device_class": "2",
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}