Baxter Healthcare recalls Kaguya Automated Peritoneal Dialysis System (Japan only) due to incorrect user guide describing Ultrafiltration settings, potentially leading to unsafe therapy termination.
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.
Baxter Healthcare is recalling the Kaguya Automated Peritone: Dialysis System sold in Japan because the user guide incorrectly describes how the Ultrafiltration (UF) limit setting works. This could cause the system to end therapy prematurely, risking patient safety.
The user guide incorrectly states that the UF volume must exceed the programmed UF limit before ending the Extra Last Drain mode. This could cause the system to terminate therapy prematurely, potentially leading to incomplete treatment.
Patients using the Kaguya Automated Peritoneal Dialysis System in Japan are affected. Those with specific dialysis needs are most at risk if the system ends therapy too early.
Check for the Kaguya Automated Peritoneal Dialysis System with product code T5C8500 sold in Japan. The system is distributed only in Japan.
Check the AMIA Sharesource User Guide for the correct UF limit function description to ensure safe therapy termination.
No, the product is distributed only in Japan.
The user guide incorrectly states that the UF volume must exceed the programmed UF limit before ending therapy, which could cause premature termination of treatment.
The product code is T5C8500 and it was sold in Japan only.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2174-2021 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-2174-2021 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
