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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00842-1
Product Name/Description Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC)

Product Code: VY-1252.030

Product Code: VY-1252.230

ARTG Number: 141227
(Device Technologies Australia Pty Ltd - Catheter, intravascular, general-purpose)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/07/2018
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue Device Technologies Australia (DTA) has been made aware by the manufacturer, VYGON GmbH & Co KG, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
Recall Action Product Defect Correction
Recall Action Instructions DTA is advising that the Instructions for Use (IFU) have been revised to provide further instructions concerning the removal of the Stylet.

The relevant segment is as follows:

"If difficulty is experienced removing the stylet stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously".

This action has been closed out on 06/02/2019
Contact Information 02 9972 8353 - Device Technologies