# FDA recall Z-1151-2021

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2021-01-07.

## Product

The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers:  a) 955626  b) 955558  c)  955701  PrisMax V2 Preventive Maintenance Kit, Product Code SC616  ARPS PUMP, Product Code SC6035  ARPS Pump Assembly, Product Code SC6053

## Reason for recall

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.

## 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 Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Jordan, Kenya, Korea (Republic Of), Kuwait, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Spain, Sweden, United Kingdom.

## Key facts

- **Recall number:** Z-1151-2021
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-07
- **Report date:** 2021-03-10
- **Termination date:** 2024-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1151-2021

## Citation

> AI Analytics. FDA recall Z-1151-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-1151-2021. Source: US FDA. Licensed CC0.

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