Baxter Healthcare recalls Revaclear 300 Dialyzer units with specific lot numbers due to potential presence of contaminants in header caps. Affected units may pose health risks requiring immediate action.
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Baxter Healthcare is recalling Revaclear 300 Dialyzer units with certain lot numbers because they may contain contaminants in the header caps. This could pose health risks to users, so affected individuals should stop using the device and contact Baxter for guidance.
The recall states there is a potential presence of particular matter in the header caps of ten specific lots. This could lead to health risks if the contaminants are introduced into the dialysis process.
Patients using the Revaclear 300 Dialyzer with the listed lot numbers are most at risk. Healthcare providers and dialysis centers that use these units may also be affected.
Check the lot numbers on your Revaclear 300 Dialyzer: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, or C419126401. The product code is 114745L.
Identify if your Revaclear 300 Dialyzer has one of the ten listed lot numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, or C419126401.
The recall states there is a potential presence of particular matter in the header caps of ten specific lots, which could pose health risks.
Check the lot numbers on your Revaclear 300 Dialyzer: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, or C419126401.
The recall does not specify a remedy, so contact Baxter Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1409-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1409-2020 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.
