Revaclear 400 dialyzers — Class II medical device recall Z-0764-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2022-12-28, distributed nationwide. Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
| Recall number | Z-0764-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-11-23 |
| Classified | 2022-12-22 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BB, BM, BS, BZ, CA, CN, CO, DE, DO, EC, EG, ES, FR, GB, GT, HN, IE, IT, MA, MX, NZ, PA, QA, SA, TT, ZA |
| Quantity | 1,140,096 units |
| Reason classes | packaging |
Product
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason for recall
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
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-0764-2023. 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.