Baxter Amia Automated Peritoneal Dialysis — Class II medical device recall Z-0550-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2023-12-20, distributed nationwide. There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on t
| Recall number | Z-0550-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2023-12-14 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 339,936 devices |
| UPC / GTIN / UDI-DI | 00085412153186 |
| Lot numbers | H23F23028, H23F24018, H23F24034, H23F24067, H23F25049, H23F25056, H23F26047, H23F26054, H23F27037, H23F27045, H23F27102, H23F28035, H23F28043, H23F29066, H23F30064, H23G01030, H23G02046, H23G05015, H23G06047, H23G07052, H23G08050, H23G09058, H23G10072, H23G11054, H23G12029, H23G13100, H23G14074, H23G15048, H23G16038, H23G17051, H23G18067, H23G19115, H23G20055, H23G22069, H23G23067, H23G24107, H23G25047, H23G25096, H23G26094, H23G27100 and 5 more |
| Model numbers | 5C5479 |
Product
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Reason for recall
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
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-0550-2024. 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.