Baxter recalls Prismaflex 7.XX control units with Product Code 115269 for potential voltage issues causing device inoperability. Update firmware to prevent malfunction.
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 control units with Product Code 115269 that may malfunction due to a voltage issue, causing the device to become inoperable. This recall is for units used in continuous renal replacement therapy and plasma exchange treatments.
The device may enter a safe state and become inoperable due to a voltage out of range malfunction. This issue occurs in a small number of units and requires firmware updates to prevent.
Patients receiving continuous renal replacement therapy or plasma exchange treatments using the Prismaflex control unit are affected. Healthcare providers using the device for patients weighing 20 kg or more are most at risk.
Check for Product Code 115269 on the Prismaflex 7.XX control units. These units are used for continuous renal replacement therapy and plasma exchange treatments for patients weighing 20 kg or more.
Baxter will release new firmware to prevent the malfunction. Users should contact Baxter for instructions on updating the firmware.
Baxter is recalling Prismaflex 7.XX control units with Product Code 115269 due to a potential voltage issue that may cause the device to become inoperable.
Check for Product Code 115269 on the Prismaflex 7.XX control unit. These units are used for continuous renal replacement therapy and plasma exchange treatments for patients weighing 20 kg or more.
No, the recall requires updating firmware to prevent the malfunction. Users can continue using the device after updating the firmware.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1925-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1925-2018 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.
