{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
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  },
  "results": [
    {
      "cfres_id": "198180",
      "product_res_number": "Z-1157-2023",
      "event_date_initiated": "2022-11-18",
      "event_date_posted": "2023-02-22",
      "recall_status": "Open, Classified",
      "res_event_number": "91560",
      "product_code": "LRS",
      "product_description": "Cardinal Health Presource Packs IV START KIT- Intended for IV access device\nCATALOG #: 01-5798B",
      "code_info": "UDI-DI:\n50195594577153(cs)\n10195594577155(ea)\n\nLot Number: 816643\nExp. Date: 2/1/2025",
      "firm_fei_number": "3001236905",
      "recalling_firm": "Cardinal Health 200, LLC",
      "address_1": "3651 Birchwood Dr",
      "city": "Waukegan",
      "state": "IL",
      "postal_code": "60085-8337",
      "reason_for_recall": "Presource Kits contains the ICU MicroClave Clear\nConnector due to a manufacturing defect there is a gap between the connectors top and bottom housings which  may lead to fluid leaks and loss of fluid path integrity",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Cardinal Health issued Urgent: Product Correction letter and Acknowledgement Form was sent overnight on November 18, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take:\n\nIf you locate affected product within your facility, please do the following:\n1. QUARANTINE affected kits.\n2. ALERT your clinicians of this action.\n3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to\nclinicians, instructing them to remove and discard the recalled component(s).\n4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this\naction and the completion of labeling product via fax to 614.652.9648.\nAdditional labels will be sent to your facility upon request. Please send an email to:\ngmb-FieldCorrectiveAction@cardinalhealth.com\nFor component credit or replacement, please contact the following:\n\" Hospitals Cardinal Customer Service at 866.551.0533\n\" Distributors Distributor Management at 800.635.6021\n\" Federal Government facilities Government Customer Service at 800.444.1166\nIf you are a Distributor and have further distributed affected kits please notify your customers of this recall.\nWe sincerely apologize for any inconvenience this notice may have caused you and your staff.  Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332",
      "product_quantity": "4560 EA",
      "distribution_pattern": "US Nationwide distribution in the states of GA, PA.",
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        "device_name": "I.V. Start Kit",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
    }
  ]
}