| 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 |
|
| 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 |