| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01419-1 |
| Product Name/Description |
Atrium Trocar Catheters, Sizes 8Fr to 32Fr
Product Code Numbers: 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432
All lot numbers
ARTG Number: 97358 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that Atrium Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. This graphical icon shows there are 6 side holes on the trocar catheter; however, the correct number of eyelets on the trocar catheter is 2 side holes.
To date, Atrium has received two complaints of insufficient drainage, with injury, as a result of selecting trocar catheters that had fewer eyelets than displayed on the product label. Although the use of a trocar catheter with two eyelets may be effective in most patients, the potential risks related to use of the trocar catheter with 2 eyelets are: incomplete drainage of pleural effusion or pneumothorax, the need for repeat chest tube or pleural drain insertion, and surgical site infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Maquet is advising customers to remove affected product from supply/inventory and place in quarantine. All sterile and un-used affected products are to be returned to Maquet for credit. Replacement product is not available as all Trocar Catheters have been discontinued however Maquet is providing information to customers about substitute product from alternative suppliers. This action has been closed-out on 25/05/2017. |
| Contact Information |
1800 605 824 - Maquet Australia Customer Servce |