Baxter Healthcare recalls Revaclear 400 Dialyzer (Product Code 114749M) due to potential internal blood leaks from a twisted gasket. Not distributed in the USA. Learn what to do.
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Baxter Healthcare is recalling Revaclear 400 Dialyzers that could leak internal blood due to a twisted gasket. This recall affects patients using hemodialysis for kidney failure treatment in the U.S. because the product is not distributed there.
The dialyzer has a gasket that can twist, potentially causing internal blood leaks. This could lead to serious health risks if the leak occurs during treatment. However, the product is not distributed in the U.S., so the hazard does not apply locally.
Patients using hemodialysis for chronic or acute kidney failure in the U.S. are not affected since the product is not distributed there. No one in the U.S. owns this product.
Check for Product Code 114749M on the dialyzer. Lot numbers C422202401 through C422204701 are also associated with this recall. The product is not distributed in the USA, so no U.S. customers are affected.
Look for Product Code 114749M on the dialyzer.
No, the product is not distributed in the USA.
The recall states potential internal blood leaks due to a twisted gasket, which could cause serious health risks during dialysis treatment.
Check for Product Code 114749M and Lot Numbers C422202401 through C422204701. The product is not distributed in the USA, so no U.S. customers are affected.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0761-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0761-2023 from Baxter Healthcare. 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.
