Baxter Healthcare recalls PrisMax System Version II hemodialysis pumps with specific tubing models (955626, 955558, 955701) that may cause alarm situations during self-test and therapy, potentially interrupting treatment. The recall includes units with serial numbers listed in the record.
Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.
Baxter Healthcare is recalling specific tubing models for their PrisMax System Version II hemodialysis pumps that can cause alarm situations during self-tests and treatments. If alarms occur, therapy may be interrupted or blood loss could happen if treatment stops without returning blood to the patient.
The tubing in the Automatic Repositioning System Pump Assembly can vary in performance, leading to alarm situations during system self-tests and therapy. These alarms include specific error codes that may interrupt treatment or cause blood loss if the system stops without returning blood to the patient.
Patients using the PrisMax System Version II hemodialysis pumps with the listed tubing models (955626, 955558, 955701) and serial numbers in the record are affected. Healthcare providers who use these pumps should check their equipment.
Check if your PrisMax System Version II hemodialysis pump has tubing with model numbers 955626, 955558, or 955701. The recall includes units with serial numbers listed in the provided record.
Identify if your PrisMax System Version II hemodialysis pump has tubing with model numbers 955626, 955558, or 955701.
Check if your pump's serial number matches those listed in the official recall record.
The recall affects PrisMax System Version II hemodialysis pumps with tubing model numbers 955626, 955558, and 955701.
Affected pumps may show alarm codes B1215 (ARPS Self-Test failure), B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), or B1540 (Effluent Filter Pod Reposition Failure).
If your pump shows any of the listed alarm codes, stop using it immediately and contact Baxter Healthcare for 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-1151-2021 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1151-2021 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.
