Baxter recalls Prisma: Control units with software versions below 7.21 due to potential therapy interruptions or blood loss from communication errors. Affected units sold outside the US.
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Baxter Healthcare is recalling Prismaflex Control Units with software versions older than 7.21. These units could cause therapy interruptions or blood loss if communication errors occur, posing a risk to patients using the device.
The software may have communication errors that interrupt therapy, delay treatment, or cause blood loss by failing to properly manage blood flow in the extracorporeal circuit.
Patients using the Prismaflex Control Unit with software versions below 7.21 are affected. Those with the device in their home or medical facility are most at risk.
Check for the Prismaflex Control Unit with software version numbers below 7.21. The product code is 114870 and all lot numbers are affected. This device is not distributed in the US.
Look for the software version number on the device or its documentation to confirm it is below 7.21.
No, the device is not distributed in the US.
Software versions below 7.21.
Check the product code (114870) and software version number; affected units have software versions below 7.21.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0278-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0278-2020 from Baxter Healthcare. 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.
