FDA Medical Device Recalls (openFDA)
BAXTER HEALTHCARE CORPORATION: Kaguya Automated Peritoneal Dialysis System
- Recall number
- Z-2174-2021
- Recalling firm
- BAXTER HEALTHCARE CORPORATION
- Product
- Kaguya Automated Peritoneal Dialysis System
- Status
- Terminated
- Initiated
- 2021-06-30
- Posted
- not on file
- Terminated
- 2024-04-10
- Reason
- 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.
- 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
- 5101 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Lot, serial or model codes
- Product Code T5C8500 (distribution in Japan only)
- 510(k) numbers
- ["K151525"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28