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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01202-1
Product Name/Description	DBB-06, DBB-07 Haemodialysis Device (haemofiltration dialysis unit) Reference Numbers: GE-F110-00, GE-F111-00, GE-F112-00, GE-F114-00 & GE-F115-00 All devices with serial numbers manufactured prior to 1 October 2012 ARTG Number: 189947
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	6/12/2012
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	NIKKISO has received complaints regarding too high a patient leakage current with the DBB-06 devices, used in combination with a central venous catheter (CVC). These complaints were related to technical measurement without any patient involvement.
Recall Action	Recall for Product Correction
Recall Action Instructions	Baxter Healthcare is recommending work around instructions to mitigate the risk. A modification to the hardware is planned to correct the issue.
Contact Information	02 8845 1601 - Baxter Quality Assurance