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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01168-1
Product Name/Description	MediRedi A.V. Fistula Pack (contains the Terumo AVF Set for Haemodialysis) Product Code: FG00605 (SAP 114827) Batch Numbers: 1503091,1504158, 1505197, 1506221, 1507275, 1508296, 1508328, 1509369 Product Code: FG00620 (SAP 114539) Batch Numbers: 1503099, 1505195, 1506231, 1507263, 1508293, 1509348, 1510389 Fistula Pack contains the affected Terumo AVF Set for Haemodialysis - AVFE1525CLFG Lot Numbers: 140714I8, 141014I5, 141110I1, 150128I7, 150511I1 ARTG Number: 167750
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/12/2015
Responsible Entity	House With No Steps Hunter Valley Region
Reason/Issue	Kawasumi Laboratories Inc. in Japan has received 4 reports worldwide where the needle cannula of the A.V Fistula (AVF) 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	House with No Steps is advising users to quarantine and destroy any affected stock. This action has been closed-out on 29/08/2016.
Contact Information	02 4941 8100 - House with No Steps