Baxter Healthcare recalls Prismaflex Control Units used for CRRT due to tubing variability causing alarm situations during system 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 ARPS (Automatic Repositioning System) Pump Assembly can vary in performance, potentially causing alarm situations during or after system self-tests. This issue does not pose an immediate risk of injury but requires attention to prevent false alarms.
The tubing in the ARPS Pump Assembly can vary in performance, which may lead to false alarms during or after system self-tests. This variability does not cause physical harm but could disrupt treatment processes by triggering unnecessary alerts.
Healthcare facilities using the Prismaflex Control Unit for CRRT treatments are most at risk. Patients are not directly affected by the recall as it relates to equipment functionality rather than patient safety.
Check if your Prismaflex Control Unit has a serial number listed in the provided list (e.g., PA0105, PA0104, etc.). The product is used for Continuous Renal Replacement Therapy (CRRT) and has a GTIN of 07332414073718.
Verify if your Prismaflex Control Unit has a serial number from the list provided in the recall notice (e.g., PA0105, PA0104, etc.).
Baxter Healthcare recalls Prismaflex Control Units used for CRRT due to tubing variability in the ARPS Pump Assembly causing alarm situations during or after system self-tests.
No, the recall does not require immediate discontinuation of use. The issue is related to potential false alarms during self-tests, not an immediate safety hazard.
Check if your Prismaflex Control Unit has a serial number listed in the provided list (e.g., PA0105, PA0104, etc.).
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1277-2021 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1277-2021 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.
