{
  "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,
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  "results": [
    {
      "cfres_id": "210124",
      "product_res_number": "Z-0122-2025",
      "event_date_initiated": "2024-08-28",
      "event_date_posted": "2024-10-17",
      "recall_status": "Open, Classified",
      "res_event_number": "95393",
      "product_code": "OEZ",
      "product_description": "MEDLINE OPEN HEART, REF DYNJ904261B",
      "code_info": "UDI/DI 40193489479530 (case), 10193489479539 (each), Lot Numbers:  23LBR364",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline issued an UREGENT MEDICAL DEVICE NOTIFICATION to its consignees on 08/28/2024 via USPS first class mail and email.  The notice explained the issue, potential risk, and requested the consignee quarantine the product and response to obtain labeling to be placed on the affected inventory.  Distributors are directed to notify those to whom they shipped the affected product.",
      "product_quantity": "30 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}