| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-01029-1 |
| Product Name/Description |
BEGRAFT AORTIC STENT SYS and BEGRAFT PERIPHERAL STENT
Multiple product codes and lot numbers
ARTGs: 280061, 286040 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/11/2024 |
| Responsible Entity |
|
| Reason/Issue |
It was found that a number of supplied products had incorrect country specific labelling. For these products there is additional labelling attached to the exterior packaging which is not compliant with the regulatory requirements for Australia. In addition, the sponsor label and link to ePIL is missing. The products themselves as well as the content within the product box and the product specific labelling (e.g. REF, Lot, manufacturing date, expiration date) on the affected products are correct. The safety and effectiveness of the device is not affected.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies will contact customers to arrange for the replacement and collection of the affected devices once the response form is received. |
| Contact Information |
0438 768 634 - Device Technologies Senior Business Manager |