Agency classClass IIOur severity:High FDA (Devices)·Z-0280-2020·Announced 2019-11-13

Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

Baxter Healthcare is recalling 336 Prismaflex Control Units with software versions below 7.21 due to communication error alarms that may interrupt therapy or cause blood loss.

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 defect that poses a risk of harm (blood loss, therapy interruption) but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling 336 units of the Prismaflex Control Unit, specifically those running software versions below 7.21. The recall is due to a defect where communication error alarms may result in the interruption of therapy, a delay in therapy, or blood loss due to the non-restitution of blood in the extracorporeal circuit.

The affected devices were distributed nationwide to 48 states and the District of Columbia, as well as internationally to numerous countries including Australia, Canada, China, India, Japan, and various locations in Europe, Asia, and the Americas. The recall covers all lot numbers for Product Code 6023014700.

Healthcare facilities and users should contact Baxter Healthcare Corporation for instructions on how to address the software defect and ensure patient safety. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: Prismaflex Control Unit, software versions below 7.21
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis Equipment
Hazard: blood-loss
therapy-interruption
Affected units: 336

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 (3)

Product Code: 6023014700
All Lot numbers
GTIN: 07332414073718.

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · blood loss