Baxter Healthcare recalls Prismaflex Control Units used for CRRT due to tubing variability causing alarm situations during self-tests. Affected units have specific serial numbers listed in the recall notice.
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
Baxter Healthcare is recalling Prismaflex Control Units used for Continuous Renal Replacement Therapy (CRRT) because tubing in the Automatic Repositioning System Pump Assembly can vary in performance, potentially causing alarm situations during system self-tests. This issue does not pose an immediate risk of injury but requires attention to prevent false alarms.
The tubing in the Automatic Repositioning System Pump Assembly can vary in performance, which may lead to false alarms during system self-tests. This variability does not cause physical harm but could disrupt treatment monitoring.
Healthcare facilities using Prismaflex Control Units for CRRT treatment are most at risk. Patients receiving CRRT through this equipment may be affected if their unit is recalled.
Check if your Prismaflex Control Unit has a serial number listed in the provided list (e.g., PA9946, PA9945, etc.). The product is used for Continuous Renal Replacement Therapy (CRRT).
Verify if your unit's serial number appears in the list of affected serial numbers provided in the recall notice.
No, the recall is for potential false alarms during self-tests, not a risk of injury. The hazard is low risk.
Check if your unit's serial number is listed in the provided list of affected serial numbers (e.g., PA9946, PA9945, etc.).
Check the serial number against the list provided in the recall notice. If affected, contact Baxter Healthcare for further instructions.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1278-2021 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1278-2021 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.
