{
  "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": 8
    }
  },
  "results": [
    {
      "cfres_id": "221061",
      "product_res_number": "Z-2606-2026",
      "event_date_initiated": "2026-05-28",
      "event_date_posted": "2026-06-26",
      "recall_status": "Open, Classified",
      "res_event_number": "99209",
      "product_code": "OES",
      "product_description": "Medline Convenience kits containing recalled Swan-Ganz Catheters\n\nRIGHT HEART CATH PACK CTX\t\n\tDYNJ68530B",
      "code_info": "UDI-DI 10195327345044\t\n\tLots \n23DBI807\n\t23FBG708\n\t23GBK642\n\t23KBO477\n\t24BBG198\n\t24FBN889\n\t24GBJ879\n\t24HBR045\n\t24LBT492\n\t25ABL957\n\t25BBN572\n\t25GBT734\n\t25HBQ817\n\t25LBM617\n\t26BBK766\n\t26DBE720",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n800-633-5463",
      "reason_for_recall": "Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.",
      "root_cause_description": "Process change control",
      "action": "On May 28, 2026, the firm notified customers via letters titled \"URGENT MEDICAL DEVICE CORRECTION.\"\n\nCustomers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required.\n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "9,272 kits",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.",
      "openfda": {
        "registration_number": [
          "3010532612",
          "3007329020",
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        "fei_number": [
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          "1047429",
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        ],
        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}