{
  "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": "114388",
      "product_res_number": "Z-0434-2013",
      "event_date_initiated": "2012-11-05",
      "event_date_posted": "2012-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-18",
      "res_event_number": "63631",
      "product_code": "LKD",
      "k_numbers": [
        "K101690"
      ],
      "product_description": "SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces.  The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only.\n\nThe V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.",
      "code_info": "Lot numbers:  1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F",
      "firm_fei_number": "3004149774",
      "recalling_firm": "Sentec AG",
      "address_1": "Ringstrasse 39 39 ringstrasse",
      "city": "Therwil",
      "state": "Baselland",
      "country": "Switzerland",
      "reason_for_recall": "A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane.  The PCO2 performance of a sensor without electrolyte will be deteriorated.",
      "root_cause_description": "Component design/selection",
      "action": "SenTec notified the one US distributor via e-mail on November 5, 2012.  The distributor was advised to stop distribution of affected lot numbers.  The communication to the distributor described the issue, identified affected product, and stated that SenTec will replace current stock at the end-customer level.  The end user can discard the affected products.  The distributor is asked to respond back with an e-mail to SenTec that they took appropriate action.",
      "product_quantity": "265 boxes (5 per box)",
      "distribution_pattern": "Distributed only in MO.",
      "openfda": {
        "k_number": [
          "K041548",
          "K913013",
          "K131253",
          "K990960",
          "K980756",
          "K232516",
          "K890517",
          "K043357",
          "K905225",
          "K093154",
          "K151329",
          "K110474",
          "K900333",
          "K043003",
          "K101690",
          "K891481",
          "K883606"
        ],
        "pma_number": [
          "P820025",
          "P850087",
          "P810037",
          "P840037",
          "P810022",
          "P830008",
          "P800043",
          "P820019"
        ],
        "registration_number": [
          "3012528160",
          "3009077524",
          "9614470",
          "3016701404",
          "3000126629",
          "9610816",
          "3013513377",
          "3003263092",
          "3012409105",
          "3004149774",
          "3013596024",
          "3016618143",
          "3002807968",
          "3013500228",
          "3007490412",
          "2020676",
          "3012866928",
          "8030885"
        ],
        "fei_number": [
          "3002663379",
          "3012528160",
          "3009077524",
          "3016701404",
          "3003244961",
          "3000126629",
          "3013513377",
          "3003263092",
          "3012409105",
          "3004149774",
          "3013596024",
          "3016618143",
          "3002807968",
          "3013500228",
          "3007490412",
          "2020676",
          "3012866928",
          "3002807167"
        ],
        "device_name": "Monitor, Carbon-Dioxide, Cutaneous",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.2480",
        "device_class": "2"
      }
    }
  ]
}