Baxter recalls Amia Automated Peritoneal Dialysis Cycler Sets with REF 5C5479 due to increased failure alarms for Wet Cassette Integrity Test. Affected units have specific lot numbers and UDI/DI codes.
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Baxter is recalling Amia Automated Peritoneal Dialysis (APD) Cycler Sets with REF 5C5479 because users report more frequent failure alarms during the Wet Cassette Integrity Test. This issue could lead to improper dialysis treatment if not addressed.
The device may trigger false failure alarms during the Wet Cassette Integrity Test, which checks for leaks in the dialysis system. If alarms occur too frequently, it could indicate a problem with the system that might lead to improper treatment.
Patients using Baxter Amia APD Cycler Sets with REF 5C5479 are most at risk. Healthcare providers who use these devices for peritoneal dialysis treatments may also be affected.
Check for the product reference number REF 5C5479 on the device. Affected units have specific lot numbers listed in the recall notice, including H23F23028 through H23G31110.
Look for the product reference number REF 5C5479 on the Amia APD Cycler Set.
Reach out to Baxter Healthcare Corporation for assistance with the recall process.
Baxter is recalling these devices due to increased complaints about failure alarms during the Wet Cassette Integrity Test.
Check for the product reference number REF 5C5479 and specific lot numbers listed in the recall notice, including H23F23028 through H23G31110.
Contact Baxter Healthcare Corporation for assistance with the recall process.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0550-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0550-2024 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.
