Baxter recalls Prismaflex 5.10 control units for potential voltage issues causing device shutdowns. Update firmware to prevent inoperable state. Affected units sold for CRRT and plasma exchange treatments.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
Baxter is recalling Prismaflex 5.10 control units that may malfunction and shut down due to a voltage issue. This could disrupt critical kidney treatments and plasma exchanges if not fixed with a firmware update.
The control unit may show a voltage out of range alarm, causing it to stop working temporarily. This could interrupt life-saving treatments like CRRT or plasma exchanges if the device becomes inoperable.
Patients receiving continuous renal replacement therapy (CRRT) or plasma exchange treatments using the Prismaflex 5.10 control unit are most at risk. Healthcare providers using the device for patients weighing 20kg or more are affected.
Check for the Prismaflex 5.10 US model with Product Code 113081. The device is used for CRRT and plasma exchange treatments for patients weighing 20kg or more.
Baxter will provide new firmware to prevent the voltage malfunction that causes the device to shut down.
Baxter identified a potential voltage issue in some Prismaflex 5.10 control units that could cause the device to shut down temporarily.
No, the device can continue to be used but requires a firmware update to prevent shutdowns.
Product Code 113081 for the Prismaflex 5.10 US model.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1923-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1923-2018 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.
