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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01167-1
Product Name/Description	Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5 FME Material Number: AU850005 FME Lot Number: 53818, 54477, 54881, 55299,57807,58263 and 58667 Containing Terumo Material Number: AVFE1525CLFG Terumo Lot Numbers: 14071418,1410415,15012817,45051111 Safety AVF Needle - Fixed Wing FME Material Number: AU00086 FME Lot Number: 14071418,14101415,1411011,1505111 Terumo Material Number: AVFE1525CLFG ARTG Numbers: 121471,130567
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/12/2015
Responsible Entity	Fresenius Medical Care Packs Australia
Reason/Issue	It has been reported that 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	Fresenius is advising users to quarantine and destroy any affected units in stock. This action has been closed-out on 26/08/2016.
Contact Information	1800 011 464 - Fresenius Customer Care