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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 Bard Australia Pty Ltd
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