BAXTER HEALTHCARE CORPORATION Kaguya Automated Peritoneal Dialysis System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kaguya Automated Peritoneal Dialysis System
Brand
BAXTER HEALTHCARE CORPORATION
Lot Codes / Batch Numbers
Product Code T5C8500 (distribution in Japan only)
Products Sold
Product Code T5C8500 (distribution in Japan only)
BAXTER HEALTHCARE CORPORATION is recalling Kaguya Automated Peritoneal Dialysis System due to Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm notified its consignees by letter on 06/30/2021. The letter explained the issue with the instructions for use, specifically, That the AMIA Sharesource User Guide describes the function of the UF (ultrafiltration) Limit setting as the ending criteria of the cycler's Extra Last Drain Mode. Baxter will be sending a Follow-Up communication once the AMIA Sharesource User Guide has been updated on the portal.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026