{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "219254",
      "product_res_number": "Z-2210-2026",
      "event_date_initiated": "2026-03-24",
      "event_date_posted": "2026-05-18",
      "recall_status": "Open, Classified",
      "res_event_number": "98622",
      "product_code": "ONB",
      "k_numbers": [
        "K131549"
      ],
      "product_description": "Oncology Kit w/60\" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960",
      "code_info": "UDI-DI: 10887709083278.\nLots: 13919794, 14134777, 14196319",
      "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": "Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.",
      "root_cause_description": "Process control",
      "action": "On 3/24/2026, correction notices were emailed to customers who were asked to do the following:\n\n1) Discontinue use. Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal.\n\n2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there.\n\n3) Complete and return the attached Customer Response Form to marketaction@mailac.custhelp.com\n\nFor further inquiries, please contact firm:\nGlobal Complaint Management, globalcomplaints@icumed.com, 1-866-216-8806.\nCustomer Service, customerservice@icumed.com, 1-800-258-5361.\nField Service Processing, marketaction@mailac.custhelp.com",
      "product_quantity": "20,506",
      "distribution_pattern": "US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.",
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          "K201142",
          "K141448",
          "K172499",
          "K240171",
          "K180574",
          "K181221",
          "K192075",
          "K201099"
        ],
        "registration_number": [
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        ],
        "fei_number": [
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          "3030384100",
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          "3008002452",
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          "3008349578",
          "3008434487",
          "3002806603",
          "3013764800",
          "3002807615",
          "3018681450"
        ],
        "device_name": "Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}