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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01242-1
Product Name/Description	KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mm Product Codes: 13220, 13221, 13222, 13223 & 13224 Multiple Lot Numbers ARTG number: 215983
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/11/2014
Responsible Entity	Kimberly Clark Aust Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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.
Contact Information	02 9963 8982 - Halyard Customer Service