{
  "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": "176306",
      "product_res_number": "Z-0027-2020",
      "event_date_initiated": "2018-10-26",
      "event_date_created": "2019-10-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-12",
      "res_event_number": "83738",
      "product_code": "OES",
      "product_description": "Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580",
      "code_info": "Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05",
      "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": "Merit Customer Service\n801-208-4381",
      "reason_for_recall": "Labeling  error; It was identified that a Procedure Kit/Tray  contained  incorrect latex labeling information (i.e. indicated Latex Free)",
      "root_cause_description": "Error in labeling",
      "action": "On 10/26/2018, Merit customer service representative placed telephone calls to consignees to inform them of the latex contained in the kits/trays. On 10/29/2018, the firm  sent an \"Urgent Product recall Notice\" to all affected consignees via FedEx. The recall notification informed customers of the following: \n\n1.\tPlease immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution.\n2.\tEnsure that applicable personnel within your organization are made aware of this field action.\n3.\tIf the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities.\n4.\tPlease fill out, scan and email the completed CRF to response@merit.com within 10 business days.\n5.\tPlease immediately return all affected lots in your possession to Merit, per the instructions found in the CRF.\n6. If you have any questions concerning this communication, please  contact Merit Customer service at (801) 208-4381 or by email at response@merit.com.",
      "product_quantity": "24 kits",
      "distribution_pattern": "U.S.: VA, IL",
      "openfda": {
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        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}