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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01214-1
Product Name/Description	MediRedi Fistula Packs Melbourne Health Unit Fistula Pack Product Code: FG00605 (SAP 114827) Batch Numbers: 1503091, 1504158, 1505197, 1506221, 1705275, 1508296, 1508328, 1509369 Melbourne Health Unit Fistula Pack Product Code: FG00620 (SAP 114539) Batch Numbers: 1503099, 1505195, 1506231, 1507263, 1508293, 1509348, 1510389 A.V. Fistula Set for Haemodialysis Product Code: AVFE 1525CLFG Batch Numbers: 140714I8, 141014I5, 141110I1, 150128I7, 150511I1 ARTG Number: 167750
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/12/2015
Responsible Entity	House With No Steps Hunter Valley Region
Reason/Issue	There are four reports worldwide, where the needle cannula of the AV Fistula Set for Haemodialysis had separated from the needle hub and remained in the patients’ 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	Baxter is advising 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 stock. This action has been closed-out on 29/08/2016.
Contact Information	03 9389 3005 - Baxter