Z-2174-2021Class II

Kaguya Automated Peritoneal Dialysis System

Name: Z-2174-2021 Kaguya Automated Peritoneal Dialysis System
Creator: Baxter Healthcare Corporation
Published: 2021-06-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-06-30 / Terminated

FDA source

BAXTER HEALTHCARE CORPORATION began a recall of Kaguya Automated Peritoneal Dialysis System on 2021-06-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2174-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-30
Posted: 2021-08-02
Terminated: 2024-04-10
Recalling firm: Baxter Healthcare Corporation
Product: Kaguya Automated Peritoneal Dialysis System
Product code: FKX System, Peritoneal, Automatic Delivery
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 5101 units
Distribution: Worldwide distribution - US Nationwide distribution and the country of Japan.
Product codes and lots: Product Code T5C8500 (distribution in Japan only)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2174-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2173-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2174-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-02

Product code FKX

K151525Class IIAmia Automated PD System with SharesourceDeka Research and Development / cleared 2015-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)