{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197194",
      "product_res_number": "Z-0751-2023",
      "event_date_initiated": "2022-11-04",
      "event_date_posted": "2022-12-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2026-03-18",
      "res_event_number": "91180",
      "product_code": "OFD",
      "product_description": "Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit",
      "code_info": "UDI/DI 10809160156681, Lot Numbers:  297223, 297418",
      "firm_fei_number": "1030451",
      "recalling_firm": "Medical Action Industries, Inc. 306",
      "address_1": "25 Heywood Rd",
      "city": "Arden",
      "state": "NC",
      "postal_code": "28704-9302",
      "reason_for_recall": "XXX",
      "root_cause_description": "Under Investigation by firm",
      "action": "The recalling firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION  to its sole consignee by email on 11/04/2022.  The notice explained the issue and request the following actions be taken:  \n\"Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\nA labeling template for each LOT is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user information to quality@owens-minor.com.\"\n\"If you have any questions, please send an email to Quality@owens-minor.com.\"",
      "product_quantity": "198 cases",
      "distribution_pattern": "US Nationwide distribution in the state of VA.",
      "openfda": {
        "registration_number": [
          "1422634",
          "3004519921",
          "3005595283",
          "1928237",
          "3008500478",
          "1423395",
          "3015173212",
          "1061124",
          "3008998256",
          "1030451",
          "3005012805",
          "3009746061",
          "3045816902",
          "3045816907",
          "1526863",
          "3035642068"
        ],
        "fei_number": [
          "3000717925",
          "3005595283",
          "1928237",
          "3005012805",
          "3015173212",
          "1030451",
          "3008998256",
          "1526863",
          "3009746061",
          "3045816902",
          "3045816907",
          "3035642068",
          "1000512168",
          "1713910",
          "3005846326",
          "1000514656"
        ],
        "device_name": "Catheter Introducer Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1340",
        "device_class": "2"
      }
    }
  ]
}