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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