{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "cfres_id": "184633",
      "product_res_number": "Z-0751-2021",
      "event_date_initiated": "2020-11-10",
      "event_date_created": "2020-12-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-10-05",
      "res_event_number": "86831",
      "product_code": "OEQ",
      "product_description": "Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105\n\nFor Angiography/angioplasty.\nThe contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.",
      "code_info": "(01)00884450515105    Lot # T1907711.",
      "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": "Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a  compromised sterile barrier.  This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.",
      "root_cause_description": "Packaging process control",
      "action": "On November 10, 2020, Merit Medical sent a \"Urgent Product Recall Notice to affected consignees via FedEx mail  In addition, to informing consignees about the recall issue, the firm ask consignees to take the following actions:\n\n1. Please immediately determine if any of the devices identified in the attached Customer Response\nForm (CRF) are within your facility, quarantine them, and discontinue use and distribution.\n\n2. Ensure that applicable personnel within your organization are made aware of this field action.\n\n3. If the product has been further distributed to other facilities, institutions, or manufacturers, please\nensure this notice is immediately shared with them and note the quantity distributed on the CRF.\nAdditional distribution details may be required by health authorities.\n\n4. Please fill out, scan and email the completed Customer Response Form to Customer Service at\nresponse@merit.com within 10 days. All affected product shipped to you must be accounted for on\nthe CRF.\n\n5. Please immediately return all affected lots in your possession to Merit, per the instructions in the\nattached CRF.\n\n6. If you have any questions concerning this communication, please dont hesitate to contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381.",
      "product_quantity": "80 kits",
      "distribution_pattern": "US distribution to: KY, RI, and MD",
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        "device_name": "Angiography/Angioplasty Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}