Baxter recalls Prisma: Control units with software versions below 7.21 due to communication errors that could interrupt therapy or cause blood loss. Affected units have specific product codes and lot numbers.
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 is recalling Prismaflex Control Units with software versions older than 7.21. These units may cause therapy interruptions or blood loss due to communication errors in the blood circuit.
The software error can interrupt blood therapy or cause blood to not circulate properly in the extracorporeal circuit, leading to potential blood loss. This happens when the device's communication system fails to alert about critical issues.
Healthcare providers using the Prismaflex Control Unit with outdated software are most at risk. Patients receiving blood treatments through this device could experience complications.
Check for the product code 107493 and software versions below 7.21 on the Prismaflex Control Unit. All lot numbers and GTIN 07332414073718 are affected.
Contact Baxter Healthcare to update the software to version 7.21 or higher to fix the communication error.
Software versions below 7.21 are affected.
Check for product code 107493 and software versions below 7.21 on the Prismaflex Control Unit.
The hazard could cause therapy interruptions or blood loss, but the remedy requires updating software to fix the issue.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0276-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0276-2020 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.
