Baxter recalls Prismaflex Control Units used for CRRT due to tubing variability causing alarm situations during self-tests. Affected units have specific serial numbers and GTINs. Consumers should check their device.
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 is recalling Prismaflex Control Units used for Continuous Renal Replacement Therapy (CRRT) because tubing variability can cause alarm situations during or after system self-tests. This may lead to unexpected alerts that could disrupt treatment.
The Prismaflex Control Unit's ARPS (Automatic Repositioning System) Pump Assembly has tubing that varies in performance. This variability can cause the system to trigger alarm situations during or after self-tests, potentially disrupting critical treatment.
Healthcare professionals using the Prismaflex Control Unit for CRRT treatments are most at risk. Patients receiving CRRT care through this device could be affected if their equipment is recalled.
Check if your Prismaflex Control Unit has serial numbers listed in the provided list (e.g., PA18954, PA18949) or GTIN 07332414117702 (product code 115269) or GTIN 07332414124236 (product code 955542).
Verify your Prismaflex Control Unit's serial number against the list of affected serial numbers provided in the recall notice.
The Prismaflex Control Unit is used for Continuous Renal Replacement Therapy (CRRT).
Check your device's serial number against the list of affected serial numbers provided in the recall notice, which includes specific PA numbers like PA18954, PA18949, etc.
The recall notice does not specify a remedy, so you should contact Baxter Healthcare Corporation directly for further instructions.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1279-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1279-2021 from Baxter. 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.
