| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00058-1 |
| Product Name/Description |
Berman Angiographic Balloon Catheters
Part numbers: AI-07130, AI-07130-J, AI-07131, AI-07132, AI-07133, AI-07134, AI-07135, AI-07136, AI-07137, AI-07138
ARTG Number: 123493 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
The labelling for the affected product numbers formerly referenced Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. The manufacturer is currently in the process of updating the labelling and Instructions for Use (IFU) for these products. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mayo Healthcare is providing an alert card within the product packaging recommending the use of contrast medium with a viscosity of 8.4 centipoise or lower. |
| Contact Information |
1300 360 226 - Mayo Healthcare Customer Service |