Kaguya Automated Peritoneal Dialysis System — Class II medical device recall Z-2174-2021
Terminated recall by BAXTER HEALTHCARE CORPORATION, reported 2021-08-11, distributed nationwide. Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA A
| Recall number | Z-2174-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BAXTER HEALTHCARE CORPORATION, Round Lake, IL, United States |
| Recall initiated | 2021-06-30 |
| Classified | 2021-08-02 |
| Reported by FDA | 2021-08-11 |
| Terminated | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 5,101 units |
Product
Kaguya Automated Peritoneal Dialysis System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2174-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.