Baxter recalls Prisma: flex 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 because communication errors might stop therapy or cause blood loss. This affects medical devices used in blood treatments.
The software versions below 7.21 can cause communication errors that interrupt blood therapy. This might lead to delays in treatment or blood loss if the system doesn't properly handle blood circulation.
Patients using blood treatment devices with the recalled Prismaflex Control Units are most at risk. Healthcare providers who use these units for blood therapy may also be affected.
Check for the product code 6023014700 on the unit. The software version must be below 7.21. This recall applies to all units sold with the specific product code and lot numbers.
Look for the software version on the Prismaflex Control Unit to confirm it is below 7.21.
Software versions below 7.21 are affected.
Check the product code 6023014700 and ensure the software version is below 7.21.
The recall record does not specify a remedy, so contact Baxter Healthcare for guidance.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0280-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0280-2020 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.