Baxter recalls Kaguya Automated Peritoneal Dialysis Systems due to potential shortened dwell times during therapy cycles, which may affect treatment effectiveness.
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Baxter is recalling its Kaguya Automated Peritoneal Dialysis Systems because software issues might shorten the time the dialysis solution stays in the patient's body during treatment. This could lead to less effective dialysis and potential health risks.
The software in the Kag: Automated Peritoneal Dialysis System cyclers may cause the dialysis solution to stay in the patient's body for shorter periods than intended during treatment cycles. This could result in less effective dialysis and potential health complications.
Adult patients undergoing peritoneal dialysis who own the Kaguya system are affected. Those with specific serial numbers are most at risk.
Check the product code T5C8500 on the device. All serial numbers are affected, so any Kaguya system with this product code should be recalled.
Look for product code T5C8500 on the device to confirm if it is affected.
Yes, if your Kaguya Automated Peritoneal Dialysis System has product code T5C8500, it is affected.
Check the product code T5C8500 on your device to confirm if it is affected. If so, contact Baxter for further instructions.
The recall states potential for shortened dwell times, which may affect treatment effectiveness, but does not specify serious injury risks.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0850-2019 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0850-2019 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.