{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "214722",
      "product_res_number": "Z-2199-2025",
      "event_date_initiated": "2025-06-16",
      "event_date_posted": "2025-07-30",
      "recall_status": "Open, Classified",
      "res_event_number": "97169",
      "product_code": "QBP",
      "k_numbers": [
        "K130975"
      ],
      "product_description": "SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL\nModel no. EMZE010301",
      "code_info": "UDI-DI 00363807103016 (ea) \n10363807103013 (box)\n20363807103010 (case)\n\nLots 3144609\n3144857\n3144886\n3144967\n3145090\n3145186",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "reason_for_recall": "SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.",
      "root_cause_description": "Process control",
      "action": "On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.",
      "product_quantity": "1,427,100 eaches",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada and Panama.",
      "openfda": {
        "k_number": [
          "K190918",
          "K111992",
          "K142806",
          "K251592",
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          "K080579",
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          "K110826",
          "K121171",
          "K113842",
          "K200299",
          "K223914",
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          "3005515211",
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        ],
        "device_name": "Cap, Device Disinfectant",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}