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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00661-1
Product Name/Description Endoscan Brush Purple

Catalogue Number: PMD1013A

Lot Number: 20180120

ARTG Number: 296456
(Thermo Fisher Scientific Australia Pty Ltd - Cervical cytology brush)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 31/05/2018
Responsible Entity Thermo Fisher Scientific Australia Pty Ltd
Reason/Issue Thermo Fisher have identified that lot 20180120 has been incorrectly labelled. It was noticed that the product name on the product label is Cervix Brush (Blue) which is incorrect. The label product name should state Endoscan Brush Purple, not Cervix Brush (Blue). The outer box label is correct and states the correct product name.

The packaged product is Endoscan Brush Purple and can be used normally according to its intended use without exposing the patient to any harm or risk..
Recall Action Recall
Recall Action Instructions Thermo Fisher is advising users to inspect stock and quarantine all unused units from lot 20180120. Thermo Fisher will arrange recovery and replacement of impacted stock.

Correctly labelled product will be available in the next 3-4 weeks.

This action has been closed out on 18/02/2019
Contact Information 03 9757 4300 - Thermo Fisher