Baxter recalls Revaclear 400 Dialyzer (Product Code 114746L) due to potential internal blood leaks from a twisted gasket. Affected units include specific lot numbers. Stop using immediately if you have this device.
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Baxter is recalling Revaclear 400 Dialyzer units that could leak internal blood due to a twisted gasket. This hazard poses a serious risk to patients using hemodialysis treatments.
A twisted gasket in the dialyzer can cause internal blood leaks during hemodialysis. This may lead to serious injury or death if blood leaks into the patient's body.
Patients using hemodialysis treatments with the Revaclear 400 Dialyzer (Product Code 114746L) are affected. Those with the listed lot numbers are most at risk.
Check the product code (114746L) and lot numbers listed in the recall notice. The affected units include specific lot numbers starting with C421222601 through C422212601.
Discontinue use of the Revaclear 400 Dialyzer if you have the affected lot numbers.
The product code is 114746L.
Affected lot numbers range from C421222601 to C422212601.
A twisted gasket can cause internal blood leaks during hemodialysis, potentially leading to serious injury or death.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0760-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0760-2023 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.
