Baxter recalls Preventative Maintenance Kits G5010007 and spare parts for Prismaflex CRRT systems due to potential alarm issues during self-tests. Affected units may require attention to prevent system errors.
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 specific preventative maintenance kits and spare parts for Prismaflex CRRT systems. These items could cause alarm situations during or after system self-tests, which might lead to treatment interruptions.
The tubing in the Prismaflex Control Unit may vary in performance, causing the system to trigger alarms during or after self-tests. This could lead to treatment interruptions or errors in the dialysis process.
Healthcare facilities using Prismaflex CRRT systems with the recalled kits or spare parts are most at risk. Patients receiving continuous renal replacement therapy could be affected if the system malfunctions.
Check for the specific kit serial numbers: G5010007, G5064801, or G5006203. These are used with Prismaflex Control Units for continuous renal replacement therapy systems.
Identify if your Prismaflex system uses the recalled kit serial numbers: G5010007, G5064801, or G5006203.
The tubing in the Prismaflex Control Unit may vary in performance, causing alarm situations during or after system self-tests.
No, but you should check if your kit has a recalled serial number and contact Baxter if you are unsure.
Check the serial number against the recalled numbers (G5010007, G5064801, G5006203) and contact Baxter 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-1280-2021 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1280-2021 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.
