Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01095-1
Product Name/Description	Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok Catalogue Number: 154006 Lot Number: NGYJ0603 ARTG Number: 195134
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/11/2015
Responsible Entity	Bard Australia Pty Ltd
Reason/Issue	Bard has identified that some devices from a specific lot of product have a potential breach of the sterile barrier packaging. This defect may put patients at an increased risk of an ascending urinary tract infection. Symptoms of an infection could include fever, pain and burning sensation upon voiding.
Recall Action	Recall
Recall Action Instructions	Bard is requesting users inspect their stocks and to quarantine affected units prior to return as per the instructions in the customer letter. If customers have used any affected product, monitor the relevant patients for symptoms and signs of localised and/or systemic infection. This action has been closed-out on 22/08/2016.
Contact Information	1800 257 232 - Bard Australia