Baxter Healthcare Corporation recalls The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically t

Recalled March 10, 2021 · FDA recall Z-1151-2021 · Baxter Healthcare

Hazard

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. · FDA Class II

Units

2314 units

Sold at

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.

Description

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

Manufacturer(s)

Baxter Healthcare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →