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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01321-1
Product Name/Description	Tracoe Twist Tracheostomy Tube Size 06 Reference Number: REF 306-06 Batch Numbers: 1000123766, 1000124104, and 1000124346 ARTG Number 128498 (Intersurgical Australia Pty Ltd - Tube, tracheostomy, single use)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/10/2017
Responsible Entity	Intersurgical Australia Pty Ltd
Reason/Issue	Tracoe Medical has established at primary packaging, that some obturators of one batch (size 06) can break when inserted into the outer cannula. This may result in the breakage of the obturator whilst in the patient within the tube. If this was to occur, the broken fragments would likely be inhaled into the lower respiratory tract. In the event the breakage of the obturator is not detected, the aspirated fragments may remain in the deep respiratory tract. Should the fragments remain there over a longer period of time, in the worst case scenario, an inflammatory reaction in the respiratory tract can occur.
Recall Action	Recall
Recall Action Instructions	Intersurgical is advising users to quarantine affected stock. Intersurgical will collect stock from affected customers and provide credit. This action has been closed out on the 20/11/2018.
Contact Information	02 8048 3300 - Intersurgical