Baxter recalls REVACLEAR 400 dialyzers with specific lot numbers due to potential ruptured fibers causing blood leaks during dialysis treatment. Affected units may need replacement to prevent complications.
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Baxter is recalling REVACLEAR 400 dialyzers with certain lot numbers because they might have ruptured fibers that could cause blood leaks during dialysis. This could lead to complications for patients needing kidney treatment.
Ruptured dialyzer fibers in the recalled units could cause blood to leak during dialysis treatment. This might lead to complications like infections or other health issues for patients with kidney failure who rely on this procedure.
Patients using hemodialysis for kidney failure who own the recalled REVACLEAR 400 dialyzers with lot numbers C419205101, C419205201, or C419205301 are most at risk. Healthcare providers using these devices for treatment should also check their units.
Check the lot number on your REVACLEAR 400 dialyzer, which should be one of C419205101, C419205201, or C419205301. The product code is 114746L for the REVACLEAR 400 model.
Look for the lot number on the dialyzer, which should be one of C419205101, C419205201, or C419205301.
If you have a recalled unit, contact Baxter Healthcare Corporation to arrange for a replacement or repair.
The recall is due to a potential presence of ruptured dialyzer fibers that could cause blood leaks during dialysis treatment.
Lot numbers C419205101, C419205201, and C419205301 are affected.
No, but you should check the lot number and contact Baxter if you have a recalled unit to get a replacement.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1909-2019 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1909-2019 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.
