| 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 |
|
| 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 |