{
  "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": "150148",
      "product_res_number": "Z-0600-2017",
      "event_date_initiated": "2016-10-05",
      "event_date_created": "2016-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-10-08",
      "res_event_number": "75365",
      "product_code": "MJC",
      "k_numbers": [
        "K033477"
      ],
      "product_description": "Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile\n\nProduct Usage:\nThe catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irradiation and are distributed as a single use device. The catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction and surgical procedures. Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection. For urological use only; urinary catheters are intended for use for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.",
      "code_info": "Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.",
      "firm_fei_number": "1018233",
      "recalling_firm": "C.R. Bard, Inc.",
      "address_1": "8195 Industrial Blvd NE",
      "city": "Covington",
      "state": "GA",
      "postal_code": "30014-1497",
      "additional_info_contact": "Michael Wolfe\n770-784-6220",
      "reason_for_recall": "Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "Bard Medical  sent an Urgent Medical Device Product Recall letter dated October 5, 2016 to customers The letter identified the affected product, problem and actions to be taken.  Customers were instructed to examine and quarantine and return affected inventory.  Customers were asked to complete and return the accompanying Recall & Effectiveness Check Form attached.",
      "product_quantity": "10,290 units",
      "distribution_pattern": "US Nationwide Distribution in the states of:  CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.",
      "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",
          "8040607",
          "1043214",
          "2032098",
          "9611590"
        ],
        "fei_number": [
          "1000112968",
          "3027301746",
          "3003058448",
          "1018233",
          "3012809732",
          "3002806591",
          "1000112877",
          "3003040625",
          "3006082230",
          "1043214",
          "1000237915"
        ]
      }
    }
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}