Baxter Healthcare Corporation Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
a. UDI-DI: 07332414124076, Product Code: 114746L, All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209, Product Code: 114746M, All lot numbers from C422218601-C422219901
Products Sold
a. UDI-DI: 07332414124076; Product Code: 114746L; All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209; Product Code: 114746M; All lot numbers from C422218601-C422219901
Baxter Healthcare Corporation is recalling Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialys due to Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Recommended Action
Per FDA guidance
Baxter Healthcare notified healthcare facilities on 11/23/2022 and home patients on 11/29/2022, via first class mail. Consignees were instructed to be aware of the difference in appearances between Polyurethane Displacement and an Internal Blood Leak and ensure staff is also aware. Additionally, consignees were instructed that if there is a blood leak alarm, to follow your clinical practice to stop treatment, and if only the Polyurethane Displacement is observed, to continue use of the dialyzer. Consignees were asked to acknowledge receipt of the notification by completing and returning the response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026