Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00552-1
Product Name/Description GM-KO-67000-120 Paediatric 120” Circuit

(Anaesthetic breathing circuit)

Batch Numbers: 140813, 141222, 140915 and 141111

ARTG Number: 130242
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 24/06/2015
Responsible Entity Koala Medical Pty Ltd
Reason/Issue The O-Ring in the swivel wye connector was out of specification and causing leaks in some of the affected circuits supplied.
Recall Action Recall
Recall Action Instructions Koala Medical is requesting their customers to quarantine the affected batches. Koala Medical will arrange for the recovery and replacement of the devices. This action has been closed-out on 12/08/2016.
Contact Information 02 9979 9374 - Koala Medical