{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183844",
      "product_res_number": "Z-0065-2021",
      "event_date_initiated": "2020-09-14",
      "event_date_created": "2020-10-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-09",
      "res_event_number": "86503",
      "product_code": "OEQ",
      "product_description": "Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).",
      "code_info": "Lot is not recorded and expiration date is not identified",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries Inc",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Kassandra Cotner\n866-359-1704",
      "reason_for_recall": "Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.",
      "root_cause_description": "Process design",
      "action": "Medline Industries, Inc. had provided each consignee with a response form to return via email.  Each Response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time.\n\nMedline has provided each consignee with a response form to return or email.  Each Response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to the field action notification in the allotted time.",
      "product_quantity": "16 kits",
      "distribution_pattern": "US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.",
      "openfda": {
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        "device_name": "Angiography/Angioplasty Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}