{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "204016",
      "product_res_number": "Z-0405-2024",
      "event_date_initiated": "2023-10-13",
      "event_date_posted": "2023-11-27",
      "recall_status": "Open, Classified",
      "res_event_number": "93331",
      "product_code": "NOU",
      "k_numbers": [
        "K193586",
        "K233452"
      ],
      "product_description": "with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc  Kits: 006093, 006653,  an accessory to  ventilator device, Vivo 45LS.\n\nintended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.",
      "code_info": "UDI-DI: 05030267120505  NIV Angled Mouthpiece with Notch 22M/15F;\n             07321820060931  MPV Kit 006093;\n             07321820066537  MPV Kit 006653 \n\nMPV mouthpiece Lot Numbers: 32304444, 32305269 and 32306017",
      "firm_fei_number": "3010817335",
      "recalling_firm": "Breas Medical, Inc.",
      "address_1": "16 Esquire Rd",
      "city": "North Billerica",
      "state": "MA",
      "postal_code": "01862-2527",
      "additional_info_contact": "Chris Southerland \n617-286-5509",
      "reason_for_recall": "Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation",
      "root_cause_description": "Process control",
      "action": "Breas Medical contacted customers via telephone followed by email on 10/13/23. Letter (Breas reference: SCAR-330) states reason for recall, health risk and action to take:\nBreas Medical recommends that all those potentially affected by this notice inspect existing inventory and identify mouthpieces which have been set up with the Vivo 45 LS for patient use. All defective mouthpieces shall be discarded. Breas Medical will provide replacement NIV Angled Mouthpieces, article number 008234, for all defective inventory and for devices in patient possession, where applicable.\nTo obtain replacement NIV Angled Mouthpieces, we are asking customers to identify mouthpieces delivered from Breas since April 4, 2023 and complete the response form.\n\nWe kindly ask you to acknowledge receipt of this Field Safety Notice together with your choice to remedy the issue using attached reply form  NIV Angled Mouthpiece Field Safety Notice Distributor/Customer Reply Form. \nContact Information\nEmail: fsn@breas.com\nHelpline: +1 (855) 436-8724\nPostal Address\n16 Esquire Road, N. Billerica, MA 01862\nWeb Portal: breas.com",
      "product_quantity": "215 units",
      "distribution_pattern": "Nationwide\nForeign: Canada",
      "openfda": {
        "k_number": [
          "K160481",
          "K021981",
          "K034032",
          "K233452",
          "K123144",
          "K193586",
          "K022750"
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          "9617566",
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        "fei_number": [
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          "3003080079",
          "3000126629"
        ],
        "device_name": "Continuous, Ventilator, Home Use",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5895",
        "device_class": "2"
      }
    }
  ]
}