Baxter recalls Prismaflex 7.XX ROW control units with Product Code 114870 for potential firmware issues causing device inoperability. Affected units may require a firmware update to prevent voltage-related malfunctions.
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 7.XX ROW control units with Product Code 114870 that could malfunction due to a firmware issue. This might cause the device to shut down unexpectedly, requiring a firmware update to prevent inoperability.
The firmware issue may cause the device to enter a safe state and become inoperable due to a voltage out of range malfunction. This could disrupt critical treatments for patients requiring renal replacement therapy or plasma exchange.
Healthcare providers using the Prismaflex control unit for continuous renal replacement therapy or plasma exchange treatments. Patients receiving these treatments through the device are at risk if the unit becomes inoperable.
Check for Product Code 114870 on the Prismaflex 7.XX ROW control units. These units are used for continuous renal replacement therapy or plasma exchange treatments for patients weighing 20 kilograms or more.
Verify your device's firmware version to determine if it requires an update.
Download and install the new firmware from Baxter's official website to prevent device inoperability.
Baxter is installing new firmware to address a potential failure mode that could cause the device to shut down unexpectedly.
If the device becomes inoperable, treatments may be interrupted, which could impact patient care.
No, the device can continue to be used after installing the firmware update.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1924-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1924-2018 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.
