{
  "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": "214003",
      "product_res_number": "Z-2116-2025",
      "event_date_initiated": "2025-06-03",
      "event_date_posted": "2025-07-11",
      "recall_status": "Open, Classified",
      "res_event_number": "96903",
      "product_code": "QBP",
      "k_numbers": [
        "K130975"
      ],
      "product_description": "SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000;  SwabCap, 200-ct. Box, REF: SCXT3-2000",
      "code_info": "REF/UDI-DI/Lot(Expiration):\n\nSCXT3-5-2000/10887709097107/14258739(1-Dec-26), 14258743(1-Feb-26), 14258744(1-Dec-26), 14264200(1-Dec-26), 14272241(1-Dec-26), 14272248(1-Dec-26), 14287456(1-Dec-26), 14287459(1-Dec-26), 14287480(1-Dec-26), 14287482(1-Dec-26), 14287485(1-Dec-26), 14294832(1-Dec-26), 14272254(1-Dec-26), 14310313(1-Dec-26), 14310425(1-Dec-26), 14323354(1-Dec-26), 14287475(1-Dec-26), 14294840(1-Dec-26), 14321645(1-Jan-27), 14321652(1-Jan-27), 14331169(1-Jan-27), 14332773(1-Jan-27), 14341732(1-Oct-26), 14294825(1-Jan-27), 14303209(1-Jan-27), 14310308(1-Jan-27), 14355404(1-Jan-27), 14355409(1-Jan-27)\n\nSCXT3-2000/20887709079162/14258214(1-Jan-27), 14258206(1-Jan-27), 14258208(1-Feb-27).",
      "firm_fei_number": "2025816",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "city": "San Clemente",
      "state": "CA",
      "postal_code": "92673-6212",
      "reason_for_recall": "Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.",
      "root_cause_description": "Process control",
      "action": "On 6/3/2025, correction notices were mailed and emailed to customers who were asked to do the following:\n1) Inform all potential users of the product in your organization of this notification.\n2) Discard the affected devices following your institution's process for discarding product. If discarding the device is not immediately possible at your facility, the device should be quarantined until disposal is possible.\n3) Complete and return the Customer Response Form to icumedical2818@sedgwick.com \n5. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical2818@sedgwick.com.\n\nFor further inquiries, please contact firm at the following: Global Complaint Management, globalcomplaints@icumed.com,1-(866)-216-8806; Customer Service, customerservice@icumed.com, 1-(800)-258-5361; Field Action Processing, icumedical2818@sedgwick.com, 1-(866)-328-0114",
      "product_quantity": "1,445,600",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of TX, SD, ID, LA, IN, CO, OK, MO, MN, OR, AZ, NC, TN, VA, CA, IL, FL, MA, OH, MD, PA, NJ, NY, WA, GA, UT, MI, MS, AR, AL, NV, KS, IA, WV, HI, KY, NM and the country of CA.",
      "openfda": {
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          "K110826",
          "K121171",
          "K113842",
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        "fei_number": [
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        ],
        "device_name": "Cap, Device Disinfectant",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}