Events

Recall of Left Double Lumen Endobronchial Tube with Parker Flex-Tip

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00258-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00258-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    An overseas complaint has been received from a physician where the product was not functioning as intended for single lung ventilation. the physician had an experience where after full intubation isolation was not successful when the physician turned the patient on his side to begin the procedure. the physician’s supposition was that the anatomy of the patient shifted in a way that occluded the bronchial lumen and prevented continued lung isolation. the physician replaced the endobronchial tube with another product and completed the procedure. to date, there has been no patient injury or harm.
  • Action
    Device Technologies Australia (DTA) is requesting customers to immediately cease the use of affected devices. Customers are further requested to inspect and quarantine affected stock prior to their return to DTA for a replacement.

Device

Left Double Lumen Endobronchial Tube with Parker Flex-Tip
  • Model / Serial
    Left Double Lumen Endobronchial Tube with Parker Flex-TipProduct Codes: WL-I-PFTDL-28, WL-I-PFTDL-32, WL-I-PFTDL-35, WL-I-PFTDL-37, WL-I-PFTDL-39 and WL-I-PFTDL-41Batch Numbers: 608DL1325A, 608DL1325B, 608DL1325C, 608DL1325D, 608DL1325E and 608DL1325F ARTG Number: 170268
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd