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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 Baxter Healthcare Pty Ltd
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