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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00478-1
Product Name/Description Premicath Neonatal PICC with Stylet

Premicath with Stylet
Product Code: VY-1261.153

Premicath 1FR 20cm Split Needle
Product Code: Vy-1261.203

Premicath with Stylette
Product Code: VY-1261.205

Premicath W Pink Hub Secure Device
Product Code: VY-1261.207

Premicath 1FR 28g 30cm w/stylet
Product Code: VY-1261.306

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 5/07/2018
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) has been revised to provide further instructions concerning the removal of the Stylet.

The relevant segment is as follows:

"In order to remove the stylet, disconnect between the T-Piece and catheter hub. If difficulty is experienced 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 - Mathew Clayton