| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00217-1 |
| Product Name/Description |
Atrium Thoracic Catheters, Sizes 8Fr & 10Fr
Product Code Numbers: 8008, 8010
All Lot Numbers
ARTG Number: 97358 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Current labelling on two models of Atrium thoracic catheters requires clarification. For product code numbers 8008 (8Fr thoracic catheter) and 8010 (10Fr thoracic catheter), the graphical icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2).
To date, Atrium has not received complaints as a result of selecting thoracic catheters that had fewer eyelets than displayed on the product label. Although the use of a thoracic catheter with two eyelets may be effective in most patients, the potential risks related to use of the thoracic catheter with two eyelets are: incomplete drainage of pleural effusion or pneumothorax and/or the need for repeated chest tube or pleural drain insertion and/or surgical site infection. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The labelling will be updated for future production. In the interim, customers may continue to use the affected thoracic catheters with the current labelling, and are advised that correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2).
This action has been closed-out on 20/03/2018. |
| Contact Information |
02 8874 3100 - Maquet - Getinge Group |