{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "142274",
      "product_res_number": "Z-0565-2016",
      "event_date_initiated": "2015-11-25",
      "event_date_posted": "2015-12-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-02-29",
      "res_event_number": "72810",
      "product_code": "MJN",
      "k_numbers": [
        "K141175"
      ],
      "product_description": "RenovoCath RC 120;\nTemporary Intravascular Occluding Catheter\nModel number: MMRC120-DB-1111;\nRx only.\n\nCardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.",
      "code_info": "Model number: MMRC120-DB-1111; Lot number: B2456974A; Expiry 2016-07. Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.",
      "firm_fei_number": "3011279674",
      "recalling_firm": "RenovoRx, Inc.",
      "address_1": "4546 El Camino Real Ste 282 4546 El Camino Real",
      "address_2": "Ste 282",
      "city": "Los Altos",
      "state": "CA",
      "postal_code": "94022-1068",
      "additional_info_contact": "Ron Warren\n650-284-4433",
      "reason_for_recall": "Incorrect version of Instructions for Use were shipped to two US customers.",
      "root_cause_description": "Labeling Change Control",
      "action": "RenovoRx notified customers by phone and by mail of this issue. This notification requests that the customers remove the affected product from their inventory and remove and replace the incorrect Instructions for Use with the correct Instructions for Use provided by RenovoRx. \n\nThe customers are requested to return the incorrect Instruction for Use to RenovoRx for disposition and are requested to complete a Recall Confirmation Form enclosed to document the completion of the requested Correction.  \n\nFor further questions, please call (650) 284-4433.",
      "product_quantity": "11 units",
      "distribution_pattern": "US Distribution to the states of : CA  and  FL.",
      "openfda": {
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        "device_name": "Catheter, Intravascular Occluding, Temporary",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4450",
        "device_class": "2"
      }
    }
  ]
}