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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00854-3
Product Name/Description Intuitive Surgical Version 12 Tip Cover for 8mm Monopolar Curved Scissors (endotherapy scissors)

Part Number: INS-400180 version 12

Multiple lots affected

ARTG Number: 97369
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/08/2012
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue During the manufacturing process, the sealed edge may not have been uniformly formed and pleats or creases may have been formed which could
have the potential to compromise the barrier integrity of the pouch.
Recall Action Recall
Recall Action Instructions Identify and quarantine affected products. Return the quarantined stock to Device Technologies for replacement stock or credit.
Contact Information 1800 429 551 - Device Technologies Regulatory Affairs