{
  "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": "191361",
      "product_res_number": "Z-0562-2022",
      "event_date_initiated": "2021-12-07",
      "event_date_created": "2022-02-04",
      "recall_status": "Open, Classified",
      "res_event_number": "89369",
      "product_code": "QJZ",
      "k_numbers": [
        "K191407"
      ],
      "product_description": "Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)-\nIndicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,",
      "code_info": "Serial Numbers:\nXCONUS0013\tXCONUS0079\tXCONUS0105\tXCONUS0036\tXCONUS0044\tXCONUS0004\nXCONUS0014\tXCONUS0080\tXCONUS0109\tXCONUS0021\tXCONUS0066\tXCONUS0027\nXCONUS0017\tXCONUS0084\tXCONUS0061\tXCONUS0043\tXCONUS0089\tXCONUS0059\nXCONUS0019\tXCONUS0085\tXCONUS0051\tXCONUS0047\tXCONUS0005\tXCONUS0042\nXCONUS0020\tXCONUS0086\tXCONUS0110\tXCONUS0055\tXCONUS0010\tXCONUS0083\nXCONUS0022\tXCONUS0087\tXCONUS0111\tXCONUS0064\tXCONUS0053\tXCONUS0121\nXCONUS0023\tXCONUS0088\tXCONUS0112\tXCONUS0002\tXCONUS0056\tXCONUS0018\nXCONUS0024\tXCONUS0090\tXCONUS0113\tXCONUS0003\tXCONUS0006\tXCONUS0054\nXCONUS0030\tXCONUS0091\tXCONUS0115\tXCONUS0007\tXCONUS0052\tXCONUS0081\nXCONUS0032\tXCONUS0094\tXCONUS0116\tXCONUS0012\tXCONUS0073\tXCONUS0008\nXCONUS0039\tXCONUS0095\tXCONUS0118\tXCONUS0070\tXCONUS0009\t\nXCONUS0040\tXCONUS0096\tXCONUS0025\tXCONUS0072\tXCONUS0001\t\nXCONUS0049\tXCONUS0092\tXCONUS0026\tXCONUS0075\tXCONUS0011\t\nXCONUS0058\tXCONUS0093\tXCONUS0028\tXCONUS0082\tXCONUS0045\t\nXCONUS0067\tXCONUS0097\tXCONUS0122\tXCONUS0048\tXCONUS0065\t\nXCONUS0068\tXCONUS0098\tXCONUS0123\tXCONUS0063\tXCONUS0029\t\nXCONUS0069\tXCONUS0099\tXCONUS0124\tXCONUS0031\tXCONUS0035\t\nXCONUS0074\tXCONUS0100\tXCONUS0034\tXCONUS0071\tXCONUS0046\t\nXCONUS0076\tXCONUS0102\tXCONUS0038\tXCONUS0060\tXCONUS0050\t\nXCONUS0077\tXCONUS0103\tXCONUS0041\tXCONUS0062\tXCONUS0015\t\nXCONUS0078\tXCONUS0104\tXCONUS0033\tXCONUS0037\tXCONUS0016\t\n\nUDI: Prefix: 4057224 (+ serial number)",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "SAME\n781-6999580",
      "reason_for_recall": "Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Fresenius Medical Care issued Urgent Medical Device Correction Letter ( Novalung Sensor Box P/N F30000163 FA-2021-33-C) on 12/7/21 via USPS First Class Mail. Letter sates reason for recall, health risk and action to take:\nIn the rare event 206/208 alarms occur, you may silence the alarms intermittently using the audio pause button. If you have continued alarms, it is recommended to replace either the sensor box or the entire console if a secondary or backup sensor box is available. Reference section 6.2 of the Instructions for Use (Part Number US (Part Number US-003-2019-08). If available, switch to a backup sensor box.\nTo correct this issue, FMCRTG will update the sensor box on your Novalung console. An FMCRTG Field Service Technician will be contacting you to schedule this correction.\nFor questions or concerns, please contact your local sales representative or FMCRTG Technical Support Services at 800-405-1321.",
      "product_quantity": "115 units",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, \nPA, TN, TX, WV.",
      "openfda": {
        "k_number": [
          "K240880",
          "K191407",
          "K261335",
          "K232926"
        ],
        "registration_number": [
          "9611665",
          "3030191221",
          "3035708507",
          "3011468686",
          "9617601",
          "3002845651",
          "3016096143",
          "3012172416"
        ],
        "fei_number": [
          "3002807095",
          "3030191221",
          "3035708507",
          "3011468686",
          "3002845651",
          "3002534070",
          "3016096143",
          "3012172416"
        ],
        "device_name": "Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4100",
        "device_class": "2"
      }
    }
  ]
}