{
  "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": "142563",
      "product_res_number": "Z-0737-2016",
      "event_date_initiated": "2015-03-13",
      "event_date_posted": "2016-02-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-02-01",
      "res_event_number": "72945",
      "product_code": "DTK",
      "k_numbers": [
        "K130366"
      ],
      "product_description": "Denali Filter-Jugular/Subclavian DL950J\nDenali Filter-Femoral Delivery DL950F.\n Intravascular filters.",
      "code_info": "Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699  Product Code: DL950F Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699",
      "firm_fei_number": "2020394",
      "recalling_firm": "Bard Peripheral Vascular Inc",
      "address_1": "1625 W 3rd St",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85281-2438",
      "additional_info_contact": "Alan Rodrigues\n800-321-4254",
      "reason_for_recall": "IFU missing contraindications:   Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.",
      "root_cause_description": "Labeling Change Control",
      "action": "The firm sent out Medical Device Recall customer notification letters on 03/13/15.\n\nThe notification letter stated that there is no required action on the customer's part.  Customers were told that if the device did not meet their needs then the firm will provide a replacement unit.  \n\nEffective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit.\n\nAny questions the firm states to call Bard Canada:\n1-800-268-2862 Western Canada\n1-800-387-9473 Ontario\n1-800-387-7851 Eastern Canada",
      "product_quantity": "1,183 units",
      "distribution_pattern": "Distributed to CA only.",
      "openfda": {
        "k_number": [
          "K171712",
          "K870729",
          "K964284",
          "K150262",
          "K172584",
          "K241507",
          "K093659",
          "K925679",
          "K032426",
          "K031328",
          "K912035",
          "K122585",
          "K760152",
          "K010083",
          "K091077",
          "K874096",
          "K121629",
          "K130366",
          "K963014",
          "K852097",
          "K211874",
          "K090140",
          "K061815",
          "K211875",
          "K163699",
          "K062887",
          "K940489",
          "K233680",
          "K112119",
          "K771046",
          "K242612",
          "K162875",
          "K023116",
          "K080668",
          "K172557",
          "K944353",
          "K070514",
          "K000855",
          "K912144",
          "K120402",
          "K901454",
          "K022236",
          "K143208",
          "K052578",
          "K073090",
          "K000062",
          "K970099",
          "K082305",
          "K081410",
          "K050558",
          "K112497",
          "K901235",
          "K133243",
          "K073528",
          "K063217",
          "K010485",
          "K073374",
          "K101431",
          "K901659",
          "K963016",
          "K881604",
          "K160866",
          "K043509",
          "K140286",
          "K152765",
          "K932921",
          "K894703",
          "K181202",
          "K951508",
          "K113124",
          "K003964",
          "K240257",
          "K072240",
          "K955396",
          "K240578",
          "K760151",
          "K161218",
          "K102511",
          "K034050",
          "K121057",
          "K143405",
          "K081138",
          "K173236"
        ],
        "pma_number": [
          "P850049"
        ],
        "registration_number": [
          "1018233",
          "1721686",
          "3007156625",
          "1313046",
          "1643817",
          "3009888344",
          "3002808486",
          "3004111573",
          "3005580113",
          "3006082230",
          "1016427",
          "3013764800",
          "9616099",
          "9612452",
          "3009526575",
          "3007080617",
          "2020394",
          "1722746",
          "3002807314",
          "3010383847",
          "1625425",
          "1820334"
        ],
        "fei_number": [
          "1018233",
          "1721686",
          "1313046",
          "1643817",
          "3009888344",
          "3002808486",
          "3002806713",
          "3003528016",
          "3004111573",
          "3005580113",
          "3006082230",
          "1016427",
          "3013764800",
          "3009526575",
          "1000306216",
          "3007080617",
          "2020394",
          "3002807314",
          "3010383847",
          "1625425",
          "3008133910",
          "1820334"
        ],
        "device_name": "Filter, Intravascular, Cardiovascular",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3375",
        "device_class": "2"
      }
    }
  ]
}