Events

Recall of Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bosco Medical Australia.

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-2016-RN-00429-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00429-1
  • 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
    The manufacturer has identified two issues relating to the power supply;- that the two halves of the power supply may come apart. if the two halves are not properly closed, there is a low risk of injury by electricity. as the conductive parts are secured by a fuse, severe injury is prevented. - the screw on domes for the housing of the power supply may break, and as a result, the housing itself may partially or completely come apart due to carious factors.It cannot be ruled out that the two issues may coincide and there is a low risk of injury by electricity.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Bosco has advised users to inspect power supply units for any defects. Any affected devices should be returned to Bosco for replacement with unaffected units. This action has been closed-out on 17/08/2016.

Device

Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)
  • Model / Serial
    Cuff Controller with Clamp (monitors the cuff pressure of tracheal tubes for intubated patients)Model Number: 55-12-500Serial Numbers: 1506-CC02-0039, 1506-CC02-0040ARTG Number: 118226
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia