Baxter recalls Revaclear 400 dialyzers for potential blood leaks due to polyurethane displacement. No units sold in the USA. Affected lot numbers: C422202401 to C422227201.
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Baxter is recalling Revaclear 400 dialyzers used for kidney treatment because they might have a blood leak risk from polyurethane displacement. This could lead to serious health issues if the leak occurs during dialysis.
The dialyzers may have polyurethane displacement, which could cause a blood leak during treatment. This leak might lead to serious health complications if it occurs while the patient is undergoing dialysis.
Patients receiving hemodialysis treatment for kidney failure who use the Revaclear 400 dialyzers are most at risk. Healthcare providers using these devices in the U.S. are also affected.
Check the product code on the dialyzer for lot numbers between C422202401 and C422227201. The Revaclear 400 is indicated for chronic and acute renal failure treatment via hemodialysis.
Look for the lot number on the dialyzer, which should be between C422202401 and C422227201.
Reach out to your healthcare provider to discuss whether the dialyzer needs to be replaced or if additional steps are required.
No, the product has no distribution in the U.S. according to the recall notice.
Lot numbers from C422202401 to C422227201.
Check the product code on the dialyzer for lot numbers between C422202401 and C422227201.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0764-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0764-2023 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
