{
  "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": 6
    }
  },
  "results": [
    {
      "cfres_id": "185439",
      "product_res_number": "Z-1118-2021",
      "event_date_initiated": "2020-12-30",
      "event_date_created": "2021-02-16",
      "recall_status": "Open, Classified",
      "res_event_number": "87150",
      "product_code": "FJK",
      "k_numbers": [
        "K070414"
      ],
      "product_description": "Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.",
      "code_info": "UDI 07332414007836, All lots within expiry",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm issued a Safety Alert on 12/30/2020 by mail.  The letter explained the problem with photographs, and the hazard involved with using a device with a kinked line.   Customers identifying set with kinked tubing may contact Baxter Healthcare Center for Service to arrange for return and credit.  Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. \n\nDistributor were asked to notify their customers by distributing the letter.",
      "product_quantity": "7437480 units",
      "distribution_pattern": "Worldwide distribution.",
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        "device_name": "Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
      }
    }
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}