{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176284",
      "product_res_number": "Z-0094-2020",
      "event_date_initiated": "2019-04-24",
      "event_date_created": "2019-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-04-03",
      "res_event_number": "83584",
      "product_code": "OES",
      "k_numbers": [
        "K171957"
      ],
      "product_description": "CVC BUNDLE VANTEX 7F, 3L, 20CM\nECVC6065",
      "code_info": "2018082450 2018091850 2018121850 2018122150 2019011550 2019012450 2019013050",
      "firm_fei_number": "3008403546",
      "recalling_firm": "Centurion Medical Products Corporation",
      "address_1": "100 Centurion Way",
      "city": "Williamston",
      "state": "MI",
      "postal_code": "48895-9086",
      "additional_info_contact": "Lisa A. Carpenter\n517-546-3356",
      "reason_for_recall": "Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 24, 2019, the firm notified customers who had received kits containing BD's MaxZero product. \n\nCustomers were instructed to do the following:\n\n1. Whether or not you have product in inventory, please complete and return the\nattached Centurion Accountability Record via email- lcarpenter@centurionmp.com or\nvia fax-517-546-3356. \n2. Please share this communication with all users of the product within your\norganization, as directed in the BD letter.\n3. Report any adverse health consequences experienced with the use of this product to\nBD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting\nprogram.\nWeb: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-\n800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852-\n9787",
      "product_quantity": "181965 total",
      "distribution_pattern": "Nationwide domestic distribution.",
      "openfda": {
        "registration_number": [
          "1423537",
          "1423395",
          "3004519921",
          "3009888344",
          "3005012805",
          "1047429",
          "1061124",
          "3011137372",
          "1643817",
          "3011144486",
          "3015173212",
          "1030451",
          "3004122598",
          "3008513424",
          "1016427",
          "1824619",
          "2029015",
          "1422634",
          "9680794",
          "3045816907",
          "1018470",
          "9616099",
          "3005595283",
          "3035642068",
          "1928237",
          "9616088",
          "3045816902",
          "3004911384",
          "3004111573",
          "3007329020",
          "3010532612"
        ],
        "fei_number": [
          "3003528016",
          "3009888344",
          "3005012805",
          "1000160458",
          "3000717925",
          "3002902735",
          "1047429",
          "3001236905",
          "1000514656",
          "1643817",
          "3011144486",
          "3015173212",
          "1030451",
          "3004122598",
          "1000512168",
          "3008513424",
          "1016427",
          "1824619",
          "3005846326",
          "3003737899",
          "3005747797",
          "3045816907",
          "1018470",
          "3005595283",
          "3035642068",
          "3045816902",
          "1928237",
          "3004911384",
          "3004111573",
          "3007329020",
          "3010532612"
        ],
        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}