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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01307-1
Product Name/Description Laparascopic inserts with tube, 3.00mm

Item Numbers: RS-003-316, RS-003-325, RS-003-390

Lot Numbers: 13J028#06102952, 13J028#06082301, 06082129/28,08

ARTG Number: 141681
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/12/2013
Responsible Entity Life Healthcare Pty Ltd
Reason/Issue The manufacturer has identified a potential risk with the affected laparascopic inserts where during reprocessing, the inner lumen of these laparascopic inserts cannot be flushed out sufficiently with the recommended rising tip. Further investigation showed that all inserts, which cannot be disassembled are affected, and that this it could lead to infection.
Recall Action Recall
Recall Action Instructions The affected laparoscopic instruments have not been used and are in their original packaging. Life Healthcare is advising users to return the affected laparoscopic instruments for replacement stock .
Contact Information 02 8114 1551 - Life Healthcare Regulatory Affairs