FDA Device recall Z-0762-2023
Revaclear 300 dialyzers
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of Revaclear 300 dialyzers by Baxter Healthcare, citing reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0762-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-23 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Identifiers
| code_info | UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0762-2023%22
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