Baxter recalls AMIA Automated Peritoneal Dialysis Systems with potential for shortened dwell times during therapy cycles. Affected units distributed from Feb 2016 to Nov 2018. No remedy specified in recall notice.
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Baxter is recalling AMIA Automated Peritoneal Dialysis Systems that may cause shortened dwell times during treatment cycles. This could affect dialysis patients by reducing the effectiveness of their treatment. The recall covers units distributed from February 2016 through November 2018.
The software in these dialysis systems may cause shorter treatment cycles than intended, potentially reducing the effectiveness of dialysis therapy. This could lead to inadequate treatment for patients with kidney failure.
Adult patients undergoing peritoneal dialysis for renal failure are most at risk. The recall applies to all units distributed between February 2016 and November 2018.
Check for product code 5C9320 on the device. Affected units were distributed from February 11, 2016 through November 27, 2018.
Look for product code 5C9320 on the device to confirm if it's affected.
The recall notice does not specify any remedy.
Units were distributed from February 11, 2016 through November 27, 2018.
The software may cause shortened dwell times during treatment cycles, potentially reducing dialysis effectiveness.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0849-2019 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0849-2019 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.
