Class II — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. |
| 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. |
| Quantity | 1249272 units |
| Distribution | US Nationwide Distribution and Internationally to: Canada and Bermuda. |
| Initiated | 2019-05-31 |
| Classified | 2019-07-01 |
| Terminated | 2020-10-05 |
| Recall number | Z-1908-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corporation (Z-1908-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83015/
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