| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00095-1 |
| Product Name/Description |
Arrow QuickFlash Radial Artery Catheterisation Set
Product Code: RA-04220
Multiple Batch Numbers
ARTG 230208
(Teleflex Medical Australia Pty Ltd - Catheter, arterial) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Teleflex Medical has received complaints related to resistance of the guidewire handle/chamber during use indicating a potentially defective component.
The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
Of the 194 complaints received, none reported injury. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should immediately check their inventory for product within the scope of this recall, cease use and distribution of affected product and immediately quarantine the affected product.
Following receipt of a completed acknowledgement form, Teleflex will arrange return and credit for affected stock. |
| Contact Information |
1300 360 226 - Customer Service or recalls.anz@teleflex.com |