{
  "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": "196732",
      "product_res_number": "Z-0371-2023",
      "event_date_initiated": "2022-11-02",
      "event_date_posted": "2022-12-03",
      "recall_status": "Open, Classified",
      "res_event_number": "91103",
      "product_code": "LSZ",
      "pma_numbers": [
        "P850064S035"
      ],
      "product_description": "2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938",
      "code_info": "Catalog/UDI/Lot: 9025/10616120000034/22042320\n; and 2.5 mm LifePort Endotracheal Tube Adaptors, Lot: 22042320, inside 938/10616120000089, 00616120000082/22052381, 22052407, 22062431, 22062458, 22062478",
      "firm_fei_number": "3032745446",
      "recalling_firm": "Bunnell, Inc.",
      "address_1": "436 W Lawndale Dr",
      "city": "Salt Lake City",
      "state": "UT",
      "postal_code": "84115-2917",
      "additional_info_contact": "801-467-0800",
      "reason_for_recall": "Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.",
      "root_cause_description": "Packaging process control",
      "action": "On 11/02/22, recall notices were emailed to customers, who were asked to remove the affected adapters and affected adapters from patient circuit kits and discard.  The remainder of the Patient Circuit Kit may be retained for future use.  As a reminder, customers may use a 3.0 mm LifePort Adapter (included in each Patient Circuit Kit) to connect to a 2.5 mm endotracheal tube if this is the only available product for patient care, per the instructions for use in the User Manual (model 204) and Operator's Manual (model 203). \n\nComplete are return the acknowledgement and receipt form. Customers with additional questions are encouraged to call 800-800-4358 or email info@bunl.com",
      "product_quantity": "1606 Assemblies",
      "distribution_pattern": "US Nationwide Distribution: PA, NY, AR, AZ, TN, SC, MA, FL, CA, TX, MD, VA, NV, IL, IN, IA, HI, KY, LA, WI, GA, OH, MI, MO, MN, NJ, MS, NC, ND, NM, UT, OK, WA, RI;\n\nOUS: Canada",
      "openfda": {
        "pma_number": [
          "P850064",
          "P890034",
          "P890057",
          "P880013"
        ],
        "device_name": "Ventilator, High Frequency",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "2021710",
          "1314417",
          "1220908",
          "8030673",
          "3032745446"
        ],
        "fei_number": [
          "2021710",
          "1314417",
          "3004213967",
          "1220908",
          "3032745446"
        ]
      }
    }
  ]
}