Baxter recalls Prismaflex Control Units (Product Code 107493) for potential voltage issues causing device shutdown. Update firmware to prevent inoperable state. Affected units used in renal therapy or plasma exchange.
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 Control Units (Product Code 107493) that may malfunction due to a voltage issue, causing the device to shut down. This could disrupt critical renal therapy or plasma exchange treatments for patients. The recall requires a firmware update to prevent the shutdown.
The device may enter a safe state and become inoperable due to a voltage out of range malfunction. This could disrupt critical treatments for patients with renal failure or fluid overload. The issue affects a small number of units with specific electronics.
Healthcare facilities using the Prismaflex Control Unit for continuous renal replacement therapy or plasma exchange treatments. Patients receiving these therapies are at risk if the device becomes inoperable.
The Prismaflex Control Unit with Product Code 107493 used in continuous renal replacement therapy or plasma exchange treatments. Units sold for patients weighing 20 kilograms or more with acute renal failure or fluid overload.
Verify the current firmware version on the Prismaflex Control Unit to determine if an update is needed.
Download and install the new firmware from Baxter Healthcare to prevent the device from entering a safe state.
The recall addresses a potential issue with a small number of units that could cause the device to shut down. If the device becomes inoperable, treatment may be disrupted. Contact your healthcare provider for specific guidance.
The affected units have Product Code 107493 and are used for continuous renal replacement therapy or plasma exchange treatments for patients weighing 20 kilograms or more.
No. The recall requires a firmware update to prevent the issue. Continue using the device normally and update the firmware as instructed.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1922-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1922-2018 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.
