{
  "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,
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  },
  "results": [
    {
      "cfres_id": "169716",
      "product_res_number": "Z-0800-2019",
      "event_date_initiated": "2018-12-06",
      "event_date_created": "2019-02-05",
      "recall_status": "Open, Classified",
      "res_event_number": "81750",
      "product_code": "MJC",
      "k_numbers": [
        "K910318"
      ],
      "product_description": "BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile.  \n\nIntended for use in the drainage and/or collection and/or measurement of urine.",
      "code_info": "Product Code A319418AM;   Lot NGCT1929;   Exp. Date 11/30/2018",
      "firm_fei_number": "1018233",
      "recalling_firm": "Bard Medical Division",
      "address_1": "8195 Industrial Blvd NE",
      "city": "Covington",
      "state": "GA",
      "postal_code": "30014-1497",
      "additional_info_contact": "Mark Neal\n770-784-6119",
      "reason_for_recall": "Some SureStep\" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.",
      "root_cause_description": "Device Design",
      "action": "Bard Medical Division notified customers on about 12/06/2018 via \"MEDICAL DEVICE PRODUCT NOTIFICATION\" letter.  Customers were instructed to examine their inventory and identify any product subject to the recall, product return is not required, and if product was further distributed or transferred to notify those customers and include a copy of the medical device communication letter provided.  Questions can be directed to Customer Service at 1-800-526-4455 or BMD.FieldAction@crbard.com.",
      "product_quantity": "450 units",
      "distribution_pattern": "US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.",
      "openfda": {
        "k_number": [
          "K910318",
          "K233094",
          "K033477",
          "K993464",
          "K000251",
          "K001143",
          "K971627",
          "K040658",
          "K984136",
          "K983101"
        ],
        "device_name": "Catheter, Urological (Antimicrobial) And Accessories",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5130",
        "device_class": "2",
        "registration_number": [
          "1054241",
          "3027301746",
          "2320762",
          "1018233",
          "1055236",
          "3012809732",
          "3006082230",
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          "9611590"
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          "1018233",
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    }
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}