| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00057-1 |
| Product Name/Description |
HomeChoice Pro Automated PD System devices
Product Code: R5C8320
ARTG Number: 172780 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
2/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
HomeChoice devices have been reported to be operating at a level of noise which was louder than the product specification of 45 dB. There is a potential for delayed therapy if the patient discontinues therapy due the reported noise. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Baxter is advising users to contact treating doctors and/or nurse or Baxter Technical Services if there is a significant change in the sound level or a new, previously unheard sound when using the device. A Baxter technician will replace or rebuilt the affected parts of the device.
This action has been closed out on 25/10/2018 |
| Contact Information |
02 8845 1601 - Baxter Healthcare |