Baxter recalls Revaclear 300 dialyzers due to reported polyurethane displacement that may cause blood leaks. Affected units have specific lot numbers and were sold for kidney failure treatment.
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Baxter is recalling Revaclear 300 dialyzers used for kidney failure treatment because reports indicate polyurethane displacement could lead to blood leaks. This hazard affects specific lot numbers and requires immediate attention to prevent potential complications.
Polyurethane displacement in the dialyzer may cause a blood leak, which could lead to serious complications during hemodialysis. This issue is reported but not confirmed to cause injury in all cases.
Patients using hemodialysis for chronic or acute renal failure who own the recalled Revaclear 300 dialyzers are most at risk. The recall applies to specific lot numbers produced between certain dates.
Check the lot numbers on your dialyzer, which range from C419128801 to C422128401. The product was sold for treating kidney failure through hemodialysis.
Identify your dialyzer's lot number to confirm if it falls within the range C419128801 to C422128401.
Baxter reports polyurethane displacement in the dialyzer that might cause blood leaks during hemodialysis.
Check your dialyzer's lot number to see if it's in the range C419128801 to C422128401. If it is, contact Baxter for further instructions.
The recall reports polyurethane displacement that might cause blood leaks, but the exact risk level isn't specified in the notice.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0762-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0762-2023 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.
