{
  "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": {
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  "results": [
    {
      "cfres_id": "210520",
      "product_res_number": "Z-0562-2025",
      "event_date_initiated": "2024-10-23",
      "event_date_posted": "2024-11-27",
      "recall_status": "Open, Classified",
      "res_event_number": "95524",
      "product_code": "KDJ",
      "k_numbers": [
        "K192705"
      ],
      "product_description": "Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp,  Part Number 5C4483; use in Peritoneal Dialysis",
      "code_info": "UDI/DI 00085412007748, Lot/Serial Numbers:  H23J10051, H23J23062, H23K20066, H24C08033, H24E16080, H24F12046, H24F17045, H24G02045, H24I02090",
      "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": "There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Baxter issued a SAFETY ALERT notice to its consignees on 10/23/2024 via USPS first class mail.  The notice explains the issue and potential hazard involved.  The notice addressed to dialysis providers indicated that if a patient contacts your clinic experiencing separation of the transfer set, to replace their transfer set and contact Baxter.  Notices addressed to peritoneal patients provided the following instructions: \n\"If you experience a separation of the transfer set, please close the transfer set twist clamp and do not cut the patient line. Contact your doctor and/or nurse immediately to arrange for a transfer set replacement and further guidance.\"\nDistributors were directed to notify their customers.  \nFor general questions regarding this communication, please contact Baxter Renal Home Care Services which can be reached at 800-284-4060, option 1, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.",
      "product_quantity": "62,718",
      "distribution_pattern": "Worldwide distribution.",
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        "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2",
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