Revaclear Capillary Dialyzer 300 — Class II medical device recall Z-1409-2020
Terminated recall by Baxter Healthcare Corporation, reported 2020-03-11, distributed nationwide. There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer
| Recall number | Z-1409-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-11-15 |
| Classified | 2020-02-28 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2020-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 101,976 devices |
| UPC / GTIN / UDI-DI | 07332414123055 |
| Lot numbers | C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401 |
Product
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Reason for recall
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 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-1409-2020. 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.