AMIA Automated Peritoneal Dialysis System Product Usage: It is… — Class II medical device recall Z-0849-2019
Terminated recall by Baxter Healthcare Corporation, reported 2019-02-27, distributed nationwide. Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle
| Recall number | Z-0849-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-12-11 |
| Classified | 2019-02-20 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2021-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 7,688 devices |
| Reason classes | software |
Product
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Reason for recall
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
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-0849-2019. 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.