{
  "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": "150405",
      "product_res_number": "Z-0363-2017",
      "event_date_initiated": "2016-10-12",
      "event_date_created": "2016-11-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-09-22",
      "res_event_number": "75452",
      "product_code": "LJE",
      "k_numbers": [
        "K063632"
      ],
      "product_description": "X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081\n\nThe product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.",
      "code_info": "Lot BMZCE039, Expiration Date 2018-12-31",
      "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": "Contract manufacturer packaged an incorrect sheath with the product.  Packaged 30Fr instead of 24Fr.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "The firm, Bard Medical, sent an \"URGENT: MEDICAL DEVICE PRODUCT RECALL\" letter dated 10/13/2016 to its customers.  The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine product subject to recall; do not use or further distribute any affected product; complete and return the attached Recall & Effectiveness Check Form regardless of whether or not you have any of the affect product by fax to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com by October 24, 2016, and if you have further distributed any units of the affected lot, identify your customers and notify them at once of the product recall.\n\nIf you have any questions, contact BMD Recall Coordinator at 1-800-793-8110.",
      "product_quantity": "192 units",
      "distribution_pattern": "Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.",
      "openfda": {
        "k_number": [
          "K183035",
          "K181735",
          "K211911",
          "K980192",
          "K834476",
          "K845048",
          "K862742",
          "K942688",
          "K172929",
          "K823382",
          "K990689",
          "K024050",
          "K850287",
          "K171601",
          "K845047",
          "K891406",
          "K943893",
          "K952968",
          "K842899",
          "K191498",
          "K923097",
          "K830803",
          "K953601",
          "K833762",
          "K190903",
          "K011121",
          "K980889",
          "K961933",
          "K222705",
          "K980193",
          "K842121",
          "K952887",
          "K915209",
          "K080944",
          "K172527",
          "K183051",
          "K821776",
          "K842840",
          "K250448",
          "K981344",
          "K830226",
          "K201165",
          "K833008",
          "K121614",
          "K850286",
          "K841720",
          "K132383",
          "K181713",
          "K063632",
          "K823418",
          "K051316",
          "K920509",
          "K953547",
          "K953713",
          "K844090",
          "K160077"
        ],
        "registration_number": [
          "3030733800",
          "1018233",
          "1000121056",
          "3010155661",
          "3005099803",
          "1450395",
          "3012494290",
          "1225687",
          "3019946783",
          "1225798",
          "3005987240",
          "3007156625",
          "1644312",
          "1647149",
          "3035451914",
          "3004730544",
          "1825146",
          "3027260597",
          "3011689956",
          "3007146453",
          "3004111573",
          "3010419931",
          "3005580113",
          "3030087693",
          "2124215",
          "3006082230",
          "3011050570",
          "3007695959",
          "3012480535",
          "2183744",
          "1646831",
          "9681477",
          "3003790304",
          "1828132",
          "3043337628",
          "3004859241",
          "3010273872",
          "3030446844",
          "3033848208",
          "3003814961",
          "2030624",
          "3002807314",
          "9681260",
          "2126666",
          "3012649202",
          "3013557562",
          "1000393132",
          "9610711",
          "1625425",
          "1820334",
          "3017425975",
          "3005941719",
          "3023460764"
        ],
        "fei_number": [
          "3030733800",
          "3014447948",
          "1000117748",
          "1018233",
          "1000121056",
          "3010155661",
          "3005099803",
          "1450395",
          "3012494290",
          "3019946783",
          "3005987240",
          "3035451914",
          "3001451463",
          "3004730544",
          "1825146",
          "3027260597",
          "3011689956",
          "3007146453",
          "3004111573",
          "3010419931",
          "3005580113",
          "3030087693",
          "2124215",
          "3006082230",
          "3002807439",
          "3011050570",
          "3007695959",
          "3002806565",
          "3012480535",
          "2183744",
          "1000160215",
          "1000306139",
          "3003790304",
          "1828132",
          "3043337628",
          "3004859241",
          "3010273872",
          "3030446844",
          "3000206435",
          "3033848208",
          "3002807314",
          "2126666",
          "3001595430",
          "3012649202",
          "3002807917",
          "3013557562",
          "1000393132",
          "3002807111",
          "3008133910",
          "1625425",
          "1820334",
          "3003814961",
          "3023460764"
        ],
        "device_name": "Catheter, Nephrostomy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}