| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00602-1 |
| Product Name/Description |
Bard Rival PTA Catheters
Product code RV135610 lot # GFYG3726 only
ARTG#: 172107 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
A portion of the affected lot contains units with an incorrect compliance card affixed to the catheter hoop inside the product pouch. Specifically, the incorrect 7mm compliance card contains the incorrect balloon diameter, lengths, diameter growth (compliance), and rated burst pressure (RBP) information instead of the correct 6mm compliance card. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised of the labelling issue and provided with the correct compliance card. Bard is recommending that the affected stock is isolated and that this letter is placed in a prominent positon with the isolated stock.
This action has been closed out on the 17/10/2018. |
| Contact Information |
02 8875 4012 - Bard Australia QA Department |