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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01147-1
Product Name/Description A.V. Fistula sets for Haemodialysis - Safety AVF Needle fixed wing

Catalogue Numbers: AVFE1525CLFG and AVFE1525CPLFG

Lot Numbers: 140714I8, 141014I5, 141110I1, 150128I7, 150511I1, 140912I6, 141110I2

ARTG Number: 121471
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/11/2015
Responsible Entity Terumo Australia Pty Ltd
Reason/Issue Kawasumi Laboratories Inc. in Japan has received 4 reports worldwide where the needle cannula of the A.V Fistula set for Haemodialysis had separated from the needle hub and remained in the patient’s vein when attempting to remove the needle following the completion of the dialysis treatment. Although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.

There have been no reports of patient injury as a result of this issue.
Recall Action Recall
Recall Action Instructions Terumo advises users to stop using the A.V Fistula set for Haemodialysis from the affected population. Customers are advised to quarantine and destroy all product in the affected population. This action has been closed-out on 31/08/2016.
Contact Information 1800 837 866 - Terumo Australia