Baxter recalls Revaclear 400 dialyzers due to potential polyurethane displacement causing blood leaks. Affected units have specific lot numbers and product codes.
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 polyurethane displacement leading to blood leaks. This could cause serious harm during dialysis treatments.
Polyurethane displacement in the dialyzer could cause a blood leak during treatment. This might lead to serious complications if not addressed promptly.
Patients receiving hemodialysis for kidney failure and healthcare providers using the dialyzers are affected. Those with the specific lot numbers are at higher risk.
Check for the product code 114746L or 114746M with lot numbers from C421221401 to C422228501 or C422218601 to C422219901. The dialyzers are used for kidney treatment via hemodialysis.
Verify the product code and lot numbers listed in the recall notice to confirm if your dialyzer is affected.
Baxter reports polyurethane displacement in the dialyzers, which might cause blood leaks during treatment.
The recall notice does not specify a remedy, so contact Baxter directly for guidance.
Check for product codes 114746L or 114746M with lot numbers from C421221401 to C422228501 or C422218601 to C422219901.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0763-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0763-2023 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.
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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.
