Print version of this report
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 Mayo Healthcare Pty Ltd
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