Retiro De Equipo (Recall) de KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mm

Recall

RC-2014-RN-01242-1

Class I

2014-11-26

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01242-1

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.

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.