| 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)
NUTRILINE W STYLET AND MICROFLASH
Product Code: VY-1252.030
NUTRILINE TWINFLO WITH STYLET
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 |
|
| 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 |