Events

Recall of KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kimberly Clark Aust 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-2014-RN-01242-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01242-1
  • 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
    Halyard australia pty ltd on behalf of kimberly-clark australia pty ltd, is recalling certain kimvent* microcuff* subglottic suctioning endotracheal tubes following advice that the referenced product codes and lot numbers may have the inflation line detach from the endotracheal tube during use (i.E. if pulled, tugged or excess tube/patient movement occurs). the potential harms associated with the pilot balloon inflation line disconnecting from the ett lumen include the need to re-intubate the patient to re-establish an adequate cuff seal and maintain appropriate ventilation of the patient. if the inflation line detachment and resulting cuff deflation are not detected and connected in time the patient may initially lose positive end expiratory pressure and get a reduction in tidal volumes.
  • Action
    Kimberly-Clark is requesting their customers to inspect their stocks and quarantine all units of the above lot numbers. Customer Service Team Leader Halyard Australia can be contacted to arrange for a return goods authorisation and credit note to be issued. This action has been closed-out on 01/03/2016.

Device

KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mm
  • Model / Serial
    KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mmProduct Codes: 13220, 13221, 13222, 13223 & 13224Multiple Lot NumbersARTG number: 215983
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Kimberly Clark Aust Pty Ltd

Manufacturer

Kimberly Clark Aust Pty Ltd