| 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 |
|
| 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 |