Z-2174-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 11, 2021
- Initiation Date
- June 30, 2021
- Termination Date
- April 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5101 units
Product Description
Kaguya Automated Peritoneal Dialysis System
Reason for Recall
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the country of Japan.
Code Information
Product Code T5C8500 (distribution in Japan only)