Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00358-1
Product Name/Description The ARROWg+ard Blue PLUS antimicrobial catheter

Multiple Lot Numbers

ARTG Numbers: 138302, 136923, 278735, 278926 and 279697
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/04/2018
Responsible Entity Teleflex Medical Australia Pty Ltd
Reason/Issue It has been identified that certain product may have packaging that is not sealed.

In the event the packaging is compromised in this manner, sterility of the product cannot be guaranteed. If a non-sterile product is used, there is potential for an infection to occur.

To date, Teleflex Medical has not received reports of this issue in Australia.
Recall Action Recall
Recall Action Instructions Teleflex is advising customers to inspect inventory for impacted lots and identify any units that appear to be affected. These units should then be discarded and Teleflex will provide a suitable credit following receipt of the acknowledgement form suppled with the customer letter.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 1300 360 226 - Teleflex Medical Customer Service