{
  "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,
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  },
  "results": [
    {
      "cfres_id": "216749",
      "product_res_number": "Z-0424-2026",
      "event_date_initiated": "2025-10-17",
      "event_date_posted": "2025-11-04",
      "recall_status": "Open, Classified",
      "res_event_number": "97848",
      "product_code": "NIE",
      "k_numbers": [
        "K192302"
      ],
      "product_description": "MAHURKAR\" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;",
      "code_info": "REF Number: 8888102003HP;\nUDI-DI: (Individual unit) 10884521127999, (Carton) 20884521127996;\nLot number: 2418000195;",
      "firm_fei_number": "3030574705",
      "recalling_firm": "Mozarc Medical US LLC",
      "address_1": "15 Hampshire St",
      "city": "Mansfield",
      "state": "MA",
      "postal_code": "02048-1113",
      "reason_for_recall": "A potential issue with the seal integrity of header bag packaging.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On October 17, 2025, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Required Actions:\n1. Immediately quarantine and discontinue use of unused affected product. 2. Please complete and return the Customer Response Form (Attachment 1), regardless of whether unused inventory is available. 3. If you have unused inventory, please contact Customer Care at 1-877-211-1850 or via email\nuscustomercare@mozarcmedical.com to request an RGA. Please copy your local sales representative on this email. 4. Share this notice with those who need to be aware within your organization or to any organization including,\nbut not limited to, surgeons, interventionalists, or other staff. Please maintain a copy of this notice in your records. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention\nto this matter. If you have questions regarding this communication, please contact your local representative or Customer Care at 1-877-211-1850, option 1 (Monday   Friday 8:00 a.m. to 5:00 p.m. CST).",
      "product_quantity": "3,258 units",
      "distribution_pattern": "US Nationwide distribution.",
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        ],
        "device_name": "Catheter, Hemodialysis, Triple Lumen, Non-Implanted",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2"
      }
    }
  ]
}