Baxter recalls Prismaflex Control Units with software versions below 7.21 due to potential therapy interruptions and blood loss risks. 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 Prisma: flex Control Units with software versions older than 7.21. These units could cause therapy interruptions or blood loss if communication errors occur.
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 Baxter's Prismaflex Control Units with software versions below 7.21 are affected. Healthcare providers managing these units are at higher risk.
Check for product codes 115269 (GTIN: 07332414117702) or 955542 (GTIN: 07332414124236). All lot numbers are affected. The software version must be below 7.21.
Verify the software version on your Prismaflex Control Unit. If it is below 7.21, it is affected.
Reach out to Baxter Healthcare Corporation for guidance on next steps or potential remedies.
Software versions below 7.21 are affected.
Check for product codes 115269 (GTIN: 07332414117702) or 955542 (GTIN: 07332414124236) and ensure the software version is below 7.21.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0279-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0279-2020 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.
