Revaclear 400 Dialyzer — Class II medical device recall Z-0760-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2022-12-28, distributed nationwide. Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
| Recall number | Z-0760-2023 |
|---|---|
| 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 | 3,610,944 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07332414124076 |
| Lot numbers | C421222601, C421222701, C421222801, C421222901, C421223001, C421223101, C421223201, C421223301, C421223401, C421223501, C421223601, C421223701, C421223801, C421223901, C421224001, C421224101, C421224201, C421224301, C421224401, C421224601, C421224701, C421224801, C421224901, C421225001, C421225101, C421225201, C421225301, C421225401, C421225501, C421225601, C421225701, C421225801, C421225901, C421226001, C421226101, C421226201, C421226301, C421226401, C421226501, C421226601 and 140 more |
Product
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Reason for recall
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
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-0760-2023. 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.