Kaguya Automated Peritoneal Dialysis System recallZ-2174-2021 · Baxter Healthcare Corporation · initiated Jun 30, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2174-2021
- Status
- Terminated
- Initiated by the company
- Jun 30, 2021
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 5101 units
- Product code
- FKX
- FDA submissions
- K151525
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
Product description
Kaguya Automated Peritoneal Dialysis System
Code information (models, lots, serial numbers)
Product Code T5C8500 (distribution in Japan only)
Other devices under the same FDA submission
4 devices cleared under K151525 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sharesource Connectivity Platform 5C9400Baxter International Inc. · System, peritoneal, automatic delivery1 recall0 reports
- Sharesource Connectivity Platform 5C9400Baxter International Inc. · System, peritoneal, automatic delivery1 recall0 reports
- AMIA Automated PD Cycler 5C9320Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY7 deaths43 reports
- Sharesource Connectivity Platform 5C9400Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 88219).
- Z-2173-2021 · TerminatedSharesource Connectivity Platform for Use with the Amia Automated PD System
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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