{
  "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": "48634",
      "product_res_number": "Z-0125-2007",
      "event_date_initiated": "2006-09-27",
      "event_date_posted": "2006-11-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-08-12",
      "res_event_number": "36426",
      "product_code": "BTS",
      "k_numbers": [
        "K961977"
      ],
      "product_description": "Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bronchial intubation; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16037",
      "code_info": "catalog (REF) number 5-16037, lot number 1188199",
      "firm_fei_number": "3004959265",
      "recalling_firm": "Teleflex Medical",
      "address_1": "2345 Waukegan Rd Ste 120 2345 Waukegan Rd",
      "address_2": "Ste 120",
      "city": "Bannockburn",
      "state": "IL",
      "postal_code": "60015-1580",
      "additional_info_contact": "Ms. Julie McDowell \n610-948-2836",
      "reason_for_recall": "Biological indicator failed.   Investigation eliminated all equipment and product related factors.",
      "root_cause_description": "Other",
      "action": "Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.",
      "product_quantity": "175 units",
      "distribution_pattern": "Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and  New Zealand",
      "openfda": {
        "k_number": [
          "K902116",
          "K834565",
          "K951091",
          "K771219",
          "K833297",
          "K953963"
        ],
        "device_name": "Tube, Bronchial (W/Wo Connector)",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5720",
        "device_class": "2",
        "registration_number": [
          "3002807561",
          "3002807314",
          "3014461810",
          "3003898360",
          "3011137372",
          "8020889",
          "2936999",
          "3014656749",
          "3004365956",
          "3018094310",
          "1820334"
        ],
        "fei_number": [
          "3002807561",
          "3002807314",
          "3014461810",
          "3003898360",
          "3005747797",
          "2936999",
          "3014656749",
          "3004365956",
          "3018094310",
          "1820334",
          "3003382061"
        ]
      }
    }
  ]
}