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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00397-1
Product Name/Description Diego Elite Tubesets

Item Codes:
TS100S – Diego Elite Tubeset, Standard
TS101DC – Diego Elite Tubeset, Declog

ARTG Number: 143268
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/05/2015
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue The reason for the recall is due to a possible breach of the package’s sterile barrier, therefore compromising the sterility of the product. The breach may not be easily seen. It is important to note that there are no concerns regarding the Diego Elite product performance. However, as a result there has been a temporary disruption in the supply of Diego Elite tube sets.
Recall Action Recall
Recall Action Instructions End users are requested to cease use of any affected product and quarantine it until it is shipped back to Olympus Australia Pty Ltd. This action has been closed-out on 08/08/2016.
Contact Information 1300 132 992 - Olympus Customer Service