REVACLEAR 300 Dialyzer — Class II medical device recall Z-1908-2019
Terminated recall by Baxter Healthcare Corporation, reported 2019-07-10, distributed nationwide. There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
| Recall number | Z-1908-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-05-31 |
| Classified | 2019-07-01 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA |
| Quantity | 1,249,272 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07332414123055 |
| Lot numbers | C419105401, C419105501, C419105601, C419105701, C419105801, C419105901, C419106001, C419106101, C419106201, C419106301, C419106401, C419106501, C419106601, C419106701, C419106801, C419106901, C419107001, C419107101, C419107201, C419107301, C419107401, C419107501, C419107601, C419107701, C419107801, C419107901, C419108001, C419108101, C419108201, C419108301, C419108401, C419108501, C419108601, C419108701, C419108801, C419108901, C419109001, C419109101, C419109201, C419109301 and 19 more |
Product
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason for recall
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
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-1908-2019. 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.