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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01341-1
Product Name/Description	Dialysis Treatment Therapy Pack 105 Code Number: AU800105 Batch Number: 64588 ARTG Number: 130567 (Fresenius Medical Care Packs Australia - Dialysis start/stop set)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/10/2017
Responsible Entity	Fresenius Medical Care Packs Australia
Reason/Issue	Fresenius Medical Care Australia have identified that a specific procedure pack contains a wrong component. There is a 5008 Bibag 900g within the pack, when it should contain 4008 Bibag 900g.
Recall Action	Recall
Recall Action Instructions	Fresenius Kabi is advising users to inspect stock and quarantine the affected units. Affected packs will be replaced with unaffected stock. This action has been closed out on the 03/12/2018.
Contact Information	02 9466 8048 - Fresenius Medical Care