| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00524-1 |
| Product Name/Description |
Edwards Lifesciences QuickDraw Venous Cannula
Model codes: QD22 & QD25
All lot numbers
ARTG number: 182853
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Through routine post market surveillance data review, Edwards Lifesciences has identified new risks associated with specific removal techniques for the QuickDraw Venous Cannula product:
1. scar tissue at the incision site may create resistance and increase the withdrawal forces on the cannula.
2. when using the percutaneous technique; separation of the cannula may occur during removal if too much compressive force is applied at the incision site. This is in addition to the resistance felt if scar tissue is present. |
| Recall Action |
Recall |
| Recall Action Instructions |
Edwards Lifesciences is asking customers to quarantine any affected product and return these. Cautions for these new risks are being added to the IFU for future shipments of the cannula to provide information to users about this potential risk. |
| Contact Information |
1800 222 601 - Edwards Customer Service |