| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01015-1 |
| Product Name/Description |
HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)
Multiple catalogue and lot numbers
ARTG Numbers: 188929 and 189286 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
In some very rare cases, it was not possible to insert the guide wire through the introducer of the HLS-Cannulae. The investigation identified that the hole in the grip of the introducer was partly blocked and the guide wire could not be pushed through. The problem occurs prior to vascular access and the cannulae itself functions properly during perfusion. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected devices to MAQUET |
| Contact Information |
07 3339 3910 - MAQUET Regulatory Affairs |