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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01117-1
Product Name/Description Homechoice Pro APD System (peritoneal dialyser)

Product Code: R5C8320

Serial Number: 300905, 300882, 300928, 300889

ARTG Number: 172780
Recall Action Level Consumer
Recall Action Classification Class II
Recall Action Commencement Date 1/11/2013
Responsible Entity Baxter Healthcare Pty Ltd
Reason/Issue An occluder blade clamps the solution lines if a power failure occurs or when the cycler is off preventing uncontrolled solution delivery to the patient. The occluder may contain sharp edges and/or separate from the back plate, which may cause the occluder assembly to fail resulting in an unrecoverable SlowFlow/No Flow alarm/system error.
Recall Action Recall
Recall Action Instructions Baxter is informing the affected hospitals of the issue. Affected devices are to be returned and replaced with unaffected devices. Baxter is advising patients if there is an unrecoverable failure to perform manual peritoneal dialysis to continue therapy.
Contact Information 1800 812 740 - Baxter Homecare Customer Service