Baxter Healthcare: PrisMax System Version II Hemodialysis Pump Assembly Recall - Alarm
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63449-baxter-healthcare-prismax-system-version-ii-hemodialysis-pump-assembly-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/63449-baxter-healthcare-prismax-system-version-ii-hemodialysis-pump-assembly-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1151-2021
Cite this page
“Baxter Healthcare: PrisMax System Version II Hemodialysis Pump Assembly Recall - Alarm.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63449-baxter-healthcare-prismax-system-version-ii-hemodialysis-pump-assembly-recall. Based on FDA recall #Z-1151-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1151-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Baxter Healthcare- Product
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically- Category
Medical device
What to do — step by step
Check Your Pump Model
Identify if your PrisMax System Version II hemodialysis pump has tubing with model numbers 955626, 955558, or 955701.
Verify Serial Numbers
Check if your pump's serial number matches those listed in the official recall record.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1151-2021 (January 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1151-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.