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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00740-3
Product Name/Description	Shiley Reusable Cannula Cuffed Tracheostomy Tubes, Product codes: 8FEN, 8LPC, 8LPC-S Fenestrated, Cuffed TT, size 8 Product code: 8FEN Lot Numbers: 0910000342 - 1101001558; 110201893X - 120600700X Low Pressure Cuffed TT, size 8 Product Code: 8LPC Lot Numbers:0910000346 - 1101001823, 110200327X - 120600351X EVAC Low Pressure Cuffed TT, size 8 Product Code: 8LPC-S Lot Numbers: 0910001002 - 1103002052, 111000400X - 120600014X ARTG Numbers: 181271 & 100137
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	19/07/2012
Responsible Entity	Covidien Pty Ltd
Reason/Issue	Covidien has received customer reports on certain size 8 Shiley reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. These events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. If a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement.
Recall Action	Recall
Recall Action Instructions	Covidien is recalling affected stock and is providing phone advice concerning available alternatives.
Contact Information	02 8904 8902 - Cathy Tinsley