{
  "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": 3
    }
  },
  "results": [
    {
      "cfres_id": "162288",
      "product_res_number": "Z-1143-2018",
      "event_date_initiated": "2017-09-20",
      "event_date_created": "2018-03-20",
      "recall_status": "Terminated",
      "res_event_number": "79426",
      "product_code": "FJS",
      "k_numbers": [
        "K031351"
      ],
      "product_description": "Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B",
      "code_info": "Lot #: a) H1136644, Exp 12/31/2018, UDI (01)00884450305850(17)181231(10)H1136644; b) H1139640, Exp 12/31/18, UDI (01)00884450305850(17)181231(10)H1139640",
      "firm_fei_number": "1721504",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 W Merit Pkwy",
      "city": "South Jordan",
      "state": "UT",
      "postal_code": "84095-2416",
      "additional_info_contact": "801-253-1600",
      "reason_for_recall": "2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "On 09/20/17, an URGENT PRODUCT RECALL NOTICE was sent to all direct consignees via mail, informing them of a voluntary recall of specific lots of peritoneal dialysis catheters and catheter containing kits. Consignees were advised to immediately do the following: identify and quarantine effected devices; inform personnel to whom the devices were distributed of the field action; fill out and email the customer response form to response@merit.com within 5 days, and return effected devices within ten days using Federal Express account 112952756. Consignee questions were directed to phone: 801-208-4381 or fax: 801-316-4880. Sales representatives were sent an email communication informing them of the recall and instructing them to contact effected customers to help them return Customer Response Forms and product.",
      "product_quantity": "30",
      "distribution_pattern": "United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom",
      "openfda": {
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          "K991042",
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          "K121383",
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        "registration_number": [
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          "3002807391",
          "2527072",
          "2011171",
          "1721504",
          "1000115408"
        ],
        "device_name": "Catheter, Peritoneal, Long-Term Indwelling",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}