Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00419-1 |
Product Name/Description |
Cavafix (used for the catheterisation of vena cava)
Article Code: 4152557, 4173350, 4173759
All batches
ARTG Number: 142123 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
8/04/2014 |
Responsible Entity |
|
Reason/Issue |
In the course of internal quality checks the manufacturer discovered that aging of these products can result in deposits of particles on the surface of the catheters. To date, no harm or any other adverse patient outcome which could be associated to the above described observation has been reported to B. Braun Melsungen AG. |
Recall Action |
Recall |
Recall Action Instructions |
B.Braun is requesting their customers to inspect their stock and quarantine any units from the affected batches. All affected stock will be recovered by B.Braun and a credit note issued. This action has been closed-out on 29/01/2016. |
Contact Information |
1800 172 182 - B. Braun Australia Pty Ltd Recall Coordinator |