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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 B Braun Australia Pty Ltd
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