FDA Device recall Z-0761-2023
Revaclear 400 Dialyzer
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of Revaclear 400 Dialyzer by Baxter Healthcare, citing potential for Internal Blood Leaks due to a twisted gasket in the dialyzer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0761-2023 |
| 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 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Reason
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Identifiers
| code_info | Not distributed in the USA. Product Code: 114749M; Lot Numbers: C422202401, C422202501, C422202601, C422202701, C422202…Not distributed in the USA. Product Code: 114749M; Lot Numbers: C422202401, C422202501, C422202601, C422202701, C422202801, C422202901, C422203001, C422203101, C422203201, C422203301, C422203401, C422203501, C422203601, C422203701, C422203801, C422203901, C422204001, C422204101, C422204201, C422204301, C422204401, C422204501, C422204701. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0761-2023%22
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