| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00607-1 |
| Product Name/Description |
VTI Bayonet 20 MHz Doppler Probe (used for the intraoperative and transcutaneous critical evaluation of blood flow)
Reference Number: VTI-108660
Lot Number: 11786-37683
ARTG Number: 146966 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Vascular Technology, has identified a potential risk with the packaging for the VTI Bayonet Doppler Probe. A probe had penetrated the sterile barrier, possibly rendering the device unsterile. This represents a potential safety hazard, which could lead to infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to determine if any unused stock exists at their site. Life Healthcare representative will collect any unused stock. |
| Contact Information |
02 8114 1500 - Life Healthcare |