Agency classClass IIOur severity:High FDA (Devices)·Z-1151-2021·Announced 2021-03-10

Baxter Recalls PrisMax Hemodialysis Tubing Due to Performance Variability

Baxter Healthcare is recalling PrisMax System Version II hemodialysis tubing due to performance variability that may cause alarms and therapy interruptions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect could lead to blood loss if therapy is interrupted, which fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Baxter Healthcare Corporation is recalling the PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System (ARPS) Pump Assembly tubing. The recall involves 2,314 units of tubing with model numbers 955626, 955558, and 955701, as well as the PrisMax V2 Preventive Maintenance Kit (Product Code SC616), ARPS Pump (Product Code SC6035), and ARPS Pump Assembly (Product Code SC6053). The products were distributed worldwide, including in the United States and numerous international countries.

The recall is due to variability in the performance of the tubing, which may lead to alarm situations during system self-tests and therapy. Specific alarm codes associated with this issue include B1215, B1273, B1116, B1539, B1541, and B1540. If an alarm occurs, it may lead to a delay or interruption of hemodialysis therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur. This tubing is normally replaced during annual preventative maintenance.

Healthcare facilities and users should check their inventory for the affected model numbers and serial numbers listed in the official recall notice. If the affected tubing is in use, it should be replaced according to the manufacturer's instructions to prevent potential therapy interruptions or blood loss.

The recalled product

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…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Hemodialysis Equipment
Hazard: blood-loss
therapy-interruption
Affected units: 2,314

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Numbers: serial number
UDI
a) 955626: 101227
(01) 00085412639499 (21) 101227
101280
(01) 00085412639499 (21) 101280
101292
(01) 00085412639499 (21) 101292
101293
(01) 00085412639499 (21) 101293
101327
(01) 00085412639499 (21) 101327
101348
(01) 00085412639499 (21) 101348
101352
(01) 00085412639499 (21) 101352
101353
(01) 00085412639499 (21) 101353
101389
(01) 00085412639499 (21) 101389

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Same manufacturer · Baxter Healthcare Corporation

See all →

Moderate
Baxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Severe
Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16

Same hazard · blood loss